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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01458574




Registration number
NCT01458574
Ethics application status
Date submitted
21/10/2011
Date registered
25/10/2011
Date last updated
18/05/2017

Titles & IDs
Public title
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Scientific title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
2011-004580-79
Secondary ID [2] 0 0
A3921096
Universal Trial Number (UTN)
Trial acronym
OCTAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CP690,550
Treatment: Drugs - CP-690,550

Placebo comparator: Placebo Comparator -

Experimental: CP-690,550 5 mg Arm -

Experimental: CP-690,550 10 mg Arm -


Treatment: Drugs: Placebo
Placebo 10 mg orally (PO) twice a day (BID)

Treatment: Drugs: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)

Treatment: Drugs: CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants In Remission at Week 52
Assessment method [1] 0 0
Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants With Mucosal Healing at Week 52
Assessment method [1] 0 0
Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
Assessment method [2] 0 0
Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.
Timepoint [2] 0 0
Week 24, 52
Secondary outcome [3] 0 0
Percentage of Participants in Remission at Week 24
Assessment method [3] 0 0
Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants in Sustained Remission
Assessment method [4] 0 0
Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Timepoint [4] 0 0
Week 24, 52
Secondary outcome [5] 0 0
Percentage of Participants With Mucosal Healing at Week 24
Assessment method [5] 0 0
Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Percentage of Participants With Sustained Mucosal Healing
Assessment method [6] 0 0
Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Timepoint [6] 0 0
Week 24, 52
Secondary outcome [7] 0 0
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
Assessment method [7] 0 0
Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Timepoint [7] 0 0
Week 24, 52
Secondary outcome [8] 0 0
Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
Assessment method [8] 0 0
Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Timepoint [8] 0 0
Week 24, 52
Secondary outcome [9] 0 0
Percentage of Participants With Clinical Response at Week 24 and 52
Assessment method [9] 0 0
Clinical response was defined by a decrease from induction study (A3921094 \[NCT01465763\] or A3921095 \[NCT01458951\]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.
Timepoint [9] 0 0
Week 24, 52
Secondary outcome [10] 0 0
Percentage of Participants With Sustained Clinical Response
Assessment method [10] 0 0
Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 \[NCT01465763\] or A3921095 \[NCT01458951\]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.
Timepoint [10] 0 0
Week 24, 52
Secondary outcome [11] 0 0
Percentage of Participants in Clinical Remission at Week 24 and 52
Assessment method [11] 0 0
Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [11] 0 0
Week 24, 52
Secondary outcome [12] 0 0
Percentage of Participants in Sustained Clinical Remission
Assessment method [12] 0 0
Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [12] 0 0
Week 24, 52
Secondary outcome [13] 0 0
Percentage of Participants in Deep Remission at Week 24 and 52
Assessment method [13] 0 0
Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [13] 0 0
Week 24, 52
Secondary outcome [14] 0 0
Percentage of Participants in Sustained Deep Remission
Assessment method [14] 0 0
Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [14] 0 0
Week 24, 52
Secondary outcome [15] 0 0
Percentage of Participants in Symptomatic Remission at Week 24 and 52
Assessment method [15] 0 0
Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [15] 0 0
Week 24, 52
Secondary outcome [16] 0 0
Percentage of Participants in Sustained Symptomatic Remission
Assessment method [16] 0 0
Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [16] 0 0
Week 24, 52
Secondary outcome [17] 0 0
Percentage of Participants in Endoscopic Remission at Week 24 and 52
Assessment method [17] 0 0
Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Timepoint [17] 0 0
Week 24, 52
Secondary outcome [18] 0 0
Percentage of Participants in Sustained Endoscopic Remission
Assessment method [18] 0 0
Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Timepoint [18] 0 0
Week 24, 52
Secondary outcome [19] 0 0
Total Mayo Score at Baseline, Week 24 and 52
Assessment method [19] 0 0
Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Timepoint [19] 0 0
Baseline, Week 24, 52
Secondary outcome [20] 0 0
Change From Baseline in Total Mayo Score at Week 24 and 52
Assessment method [20] 0 0
Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.
Timepoint [20] 0 0
Baseline, Week 24, 52
Secondary outcome [21] 0 0
Percentage of Participants in Remission, Among Participants With Remission at Baseline
Assessment method [21] 0 0
Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Timepoint [21] 0 0
Week 24, 52
Secondary outcome [22] 0 0
Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
Assessment method [22] 0 0
Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Timepoint [22] 0 0
Week 24, 52
Secondary outcome [23] 0 0
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
Assessment method [23] 0 0
Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.
Timepoint [23] 0 0
Week 24, 52
Secondary outcome [24] 0 0
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Assessment method [24] 0 0
Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.
Timepoint [24] 0 0
Week 24, 52
Secondary outcome [25] 0 0
Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Assessment method [25] 0 0
Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.
Timepoint [25] 0 0
Week 24, 52

Eligibility
Key inclusion criteria
* Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
* Subjects who achieved clinical response in Study A3921094 or A3921095
* Women of childbearing potential must test negative for pregnancy prior to study enrollment
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
* Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2016
Sample size
Target
Accrual to date
Final
593
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Eastern Health-Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Belgium
State/province [21] 0 0
Antwerpen
Country [22] 0 0
Belgium
State/province [22] 0 0
Kortrijk
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Belgium
State/province [24] 0 0
Roeselare
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande Do Sul
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Canada
State/province [29] 0 0
Saskatchewan
Country [30] 0 0
Colombia
State/province [30] 0 0
Antioquia
Country [31] 0 0
Croatia
State/province [31] 0 0
Zagreb
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Hradec Kralove
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Strakonice
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Usti nad Labem
Country [35] 0 0
Denmark
State/province [35] 0 0
Aalborg
Country [36] 0 0
Denmark
State/province [36] 0 0
Aarhus C
Country [37] 0 0
Denmark
State/province [37] 0 0
Copenhagen NV
Country [38] 0 0
Denmark
State/province [38] 0 0
Hvidovre
Country [39] 0 0
Denmark
State/province [39] 0 0
Odense C
Country [40] 0 0
Estonia
State/province [40] 0 0
Tallinn
Country [41] 0 0
Estonia
State/province [41] 0 0
Tallin
Country [42] 0 0
France
State/province [42] 0 0
Amiens Cedex 1
Country [43] 0 0
France
State/province [43] 0 0
Bordeaux cedex
Country [44] 0 0
France
State/province [44] 0 0
Clichy Cedex
Country [45] 0 0
France
State/province [45] 0 0
Nantes cedex 01
Country [46] 0 0
France
State/province [46] 0 0
Paris cedex 12
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
France
State/province [48] 0 0
Reims cedex
Country [49] 0 0
France
State/province [49] 0 0
Saint Priest en Jarez
Country [50] 0 0
Germany
State/province [50] 0 0
Schlewig Holstein
Country [51] 0 0
Germany
State/province [51] 0 0
Berlin
Country [52] 0 0
Germany
State/province [52] 0 0
Halle
Country [53] 0 0
Germany
State/province [53] 0 0
Hannover
Country [54] 0 0
Germany
State/province [54] 0 0
Lüneburg
Country [55] 0 0
Germany
State/province [55] 0 0
Minden
Country [56] 0 0
Germany
State/province [56] 0 0
Ulm
Country [57] 0 0
Hungary
State/province [57] 0 0
Bekescsaba
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Hungary
State/province [59] 0 0
Debrecen
Country [60] 0 0
Hungary
State/province [60] 0 0
Gyula
Country [61] 0 0
Hungary
State/province [61] 0 0
Miskolc
Country [62] 0 0
Hungary
State/province [62] 0 0
Mosonmagyarovar
Country [63] 0 0
Hungary
State/province [63] 0 0
Pecs
Country [64] 0 0
Hungary
State/province [64] 0 0
Szeged
Country [65] 0 0
Hungary
State/province [65] 0 0
Vac
Country [66] 0 0
Israel
State/province [66] 0 0
Haifa
Country [67] 0 0
Israel
State/province [67] 0 0
Petah Tikva
Country [68] 0 0
Israel
State/province [68] 0 0
Rehovot
Country [69] 0 0
Italy
State/province [69] 0 0
Milano
Country [70] 0 0
Italy
State/province [70] 0 0
PA
Country [71] 0 0
Italy
State/province [71] 0 0
Catanzaro
Country [72] 0 0
Japan
State/province [72] 0 0
Aichi
Country [73] 0 0
Japan
State/province [73] 0 0
Hokkaido
Country [74] 0 0
Japan
State/province [74] 0 0
Hyogo
Country [75] 0 0
Japan
State/province [75] 0 0
Ibaraki
Country [76] 0 0
Japan
State/province [76] 0 0
Kagoshima
Country [77] 0 0
Japan
State/province [77] 0 0
Kochi
Country [78] 0 0
Japan
State/province [78] 0 0
Miyagi
Country [79] 0 0
Japan
State/province [79] 0 0
Osaka
Country [80] 0 0
Japan
State/province [80] 0 0
Shiga
Country [81] 0 0
Japan
State/province [81] 0 0
Tokyo
Country [82] 0 0
Japan
State/province [82] 0 0
Chiba
Country [83] 0 0
Japan
State/province [83] 0 0
Fukuoka
Country [84] 0 0
Japan
State/province [84] 0 0
Hiroshima
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Gyeonggi-do
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Republic of Korea
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Incheon
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Seoul
Country [89] 0 0
Latvia
State/province [89] 0 0
Riga
Country [90] 0 0
Netherlands
State/province [90] 0 0
Amsterdam
Country [91] 0 0
Netherlands
State/province [91] 0 0
Groningen
Country [92] 0 0
Netherlands
State/province [92] 0 0
Leiden
Country [93] 0 0
New Zealand
State/province [93] 0 0
Auckland
Country [94] 0 0
New Zealand
State/province [94] 0 0
Bay of Plenty
Country [95] 0 0
New Zealand
State/province [95] 0 0
Canterbury Region
Country [96] 0 0
New Zealand
State/province [96] 0 0
Dunedin
Country [97] 0 0
New Zealand
State/province [97] 0 0
Hamilton
Country [98] 0 0
New Zealand
State/province [98] 0 0
Wellington
Country [99] 0 0
Poland
State/province [99] 0 0
Iodzkie
Country [100] 0 0
Poland
State/province [100] 0 0
Kujawsko-pomorskie
Country [101] 0 0
Poland
State/province [101] 0 0
Mazowieckie
Country [102] 0 0
Poland
State/province [102] 0 0
Slaskie
Country [103] 0 0
Poland
State/province [103] 0 0
Bydgoszcz
Country [104] 0 0
Poland
State/province [104] 0 0
Krakow
Country [105] 0 0
Poland
State/province [105] 0 0
Lodz
Country [106] 0 0
Poland
State/province [106] 0 0
Sopot
Country [107] 0 0
Poland
State/province [107] 0 0
Warszawa
Country [108] 0 0
Poland
State/province [108] 0 0
Wroclaw
Country [109] 0 0
Romania
State/province [109] 0 0
Timis
Country [110] 0 0
Romania
State/province [110] 0 0
Bucuresti
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Russia
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Moscow
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Nizhniy Novgorod
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Novosibirsk,
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Novosibirsk
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Samara
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Yaroslavl
Country [118] 0 0
Serbia
State/province [118] 0 0
Serbia, Europe
Country [119] 0 0
Serbia
State/province [119] 0 0
Belgrade
Country [120] 0 0
Serbia
State/province [120] 0 0
Kragujevac
Country [121] 0 0
Serbia
State/province [121] 0 0
Novi Sad
Country [122] 0 0
Serbia
State/province [122] 0 0
Zrenjanin
Country [123] 0 0
Slovakia
State/province [123] 0 0
Bratislava
Country [124] 0 0
Slovakia
State/province [124] 0 0
Nitra
Country [125] 0 0
Slovakia
State/province [125] 0 0
Nove Mesto nad Vahom
Country [126] 0 0
Slovakia
State/province [126] 0 0
Presov
Country [127] 0 0
South Africa
State/province [127] 0 0
Cape Town
Country [128] 0 0
South Africa
State/province [128] 0 0
Gauteng
Country [129] 0 0
South Africa
State/province [129] 0 0
Western Cape
Country [130] 0 0
Spain
State/province [130] 0 0
Barcelona
Country [131] 0 0
Spain
State/province [131] 0 0
Madrid
Country [132] 0 0
Taiwan
State/province [132] 0 0
Taipei City
Country [133] 0 0
Ukraine
State/province [133] 0 0
Ar Krym
Country [134] 0 0
Ukraine
State/province [134] 0 0
Chernivtsi
Country [135] 0 0
Ukraine
State/province [135] 0 0
Dniepropetrovsk
Country [136] 0 0
Ukraine
State/province [136] 0 0
Kharkiv
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kyiv
Country [138] 0 0
Ukraine
State/province [138] 0 0
Lviv
Country [139] 0 0
Ukraine
State/province [139] 0 0
Odesa
Country [140] 0 0
Ukraine
State/province [140] 0 0
Uzhgorod
Country [141] 0 0
Ukraine
State/province [141] 0 0
Vinnytsia
Country [142] 0 0
Ukraine
State/province [142] 0 0
Zaporizhzhia
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Cambridgeshire
Country [144] 0 0
United Kingdom
State/province [144] 0 0
England
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Greater London
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Middlesex
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Norfolk
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01458574