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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00377598




Registration number
NCT00377598
Ethics application status
Date submitted
14/09/2006
Date registered
18/09/2006
Date last updated
2/02/2012

Titles & IDs
Public title
Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia
Scientific title
A Phase 2, Double Blind, Placebo Controlled, Dose-Ranging Study in Subjects With Postherpetic Neuralgia (PHN) to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Four Doses of TAK-583, Compared With Placebo
Secondary ID [1] 0 0
2005-005863-26
Secondary ID [2] 0 0
TAK-583-EC201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuralgia, Postherpetic 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-583
Treatment: Drugs - TAK-583
Treatment: Drugs - TAK-583
Treatment: Drugs - TAK-583
Treatment: Drugs - Placebo

Experimental: TAK-583 5 mg QD -

Experimental: TAK-583 25 mg QD -

Experimental: TAK-583 50 mg QD -

Experimental: TAK-583 100 mg QD -

Placebo Comparator: Placebo QD -


Treatment: Drugs: TAK-583
TAK-583 5 mg, tablets, orally, once daily for up to 8 weeks

Treatment: Drugs: TAK-583
TAK-583 25 mg, tablets, orally, once daily for up to 8 weeks

Treatment: Drugs: TAK-583
TAK-583 50 mg, tablets, orally, once daily for up to 8 weeks

Treatment: Drugs: TAK-583
TAK-583 100 mg, tablets, orally, once daily for up to 8 weeks

Treatment: Drugs: Placebo
TAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in average daily pain intensity score for the previous 7 days
Timepoint [1] 0 0
Week 8 or Final Visit
Secondary outcome [1] 0 0
Change from baseline to each study visit in average daily pain intensity score for the last 7 days
Timepoint [1] 0 0
At All Visits
Secondary outcome [2] 0 0
Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire
Timepoint [2] 0 0
Week 8 or Final Visit
Secondary outcome [3] 0 0
Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary)
Timepoint [3] 0 0
Week 8 or Final Visit
Secondary outcome [4] 0 0
Clinician and subject global impression of change using a 7-point scale
Timepoint [4] 0 0
Week 8 or Final Visit
Secondary outcome [5] 0 0
Change from baseline in quality of life as assessed by Short Form-36
Timepoint [5] 0 0
Week 8 or Final Visit
Secondary outcome [6] 0 0
Change from baseline in Profile of Mood States
Timepoint [6] 0 0
Week 8 or Final Visit
Secondary outcome [7] 0 0
Proportions of subjects with at least 30% and 50% reduction from baseline in average daily pain intensity score
Timepoint [7] 0 0
Week 8 or Final Visit

Eligibility
Key inclusion criteria
- Male and female subjects with postherpetic neuralgia whose pain has been present for
>3 months following healing of the herpes zoster rash.

- Subjects with an mean pain intensity score of 4 or more (determined from at least 4
daily recordings of pain intensity on an 11-point numerical scale over the preceding 7
days) during the baseline phase.

- Subjects aged 50 years and above.

- The female subject is not of child-bearing potential (eg, sterilized, postmenopausal).
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Malignancy within the past 2 years with the exception of basal cell carcinoma.

- Subjects who have undergone neurolytic or neurosurgical therapy for postherpetic
neuralgia.

- Clinically significant, actively treated or unstable hepatic, biliary, respiratory,
renal, rheumatologic, or hematologic illnesses, or unstable cardiovascular disease as
assessed by the investigator.

- WBC less than 2500, ANC less than 1500, platelets less than 100,000; ALT, AST or
alkaline phosphatase greater than 1.5x ULN; total bilirubin greater than or equal to
1.2 times the upper limit of normal (excluding Gilbert's Disease); predicted GFR using
Cockcroft and Gault formula less than or equal to 40 mL/min.

- Subjects with greater than 5 red blood cells per high-power field on urinalysis.

- Subjects with an albumin/creatinine ratio in an untimed ("spot") morning urine
specimen greater than the upper limit of normal.

- Subjects who are immunocompromised or have clinically significant haematological
abnormalities.

- Subjects with a history of HIV infection.

- Subjects with a positive hepatitis panel (including hepatitis B surface antigen,
antibody to hepatitis B core antigen, antibody to hepatitis B surface antigen, or
antibody to hepatitis C virus), except subjects with positive antibodies to hepatitis
B surface antigen who have received hepatitis B vaccination and who have no history of
serological evidence of liver disease.

- Subjects having other severe pain which may impair the self assessment of the pain due
to postherpetic neuralgia.

- Subjects who have participated in a clinical trial for an investigational drug and/or
agent within 30 days prior to baseline.

- Subjects who have received TAK-583 in a previous clinical study.

- Subjects who have donated more than 400 mL of blood in the 90 days prior to the
beginning of the study.

- Subjects who have a history of alcohol or illicit drug abuse in the past 2 years

- Clinically significant abnormal 12 lead electrocardiogram, including QT interval
corrected for heart rate greater than 450 ms that is confirmed on a repeat
electrocardiogram.

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 2/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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Kipparing
Recruitment hospital [3] 0 0
- Maroochydore
Recruitment hospital [4] 0 0
- Box Hill
Recruitment hospital [5] 0 0
- Carlton
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Kipparing
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- Carlton
Recruitment postcode(s) [6] 0 0
- Fitzroy
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Hradec Kralove
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Moravska Ostrava
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Olomouc
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Ostrava
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Plzen
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Dresden
Country [9] 0 0
Germany
State/province [9] 0 0
Frankfurt
Country [10] 0 0
Germany
State/province [10] 0 0
Goerlitz
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Jena
Country [13] 0 0
Germany
State/province [13] 0 0
Leipzig
Country [14] 0 0
Germany
State/province [14] 0 0
Magdeburg
Country [15] 0 0
Germany
State/province [15] 0 0
Schwerin
Country [16] 0 0
Netherlands
State/province [16] 0 0
Arnhem
Country [17] 0 0
Netherlands
State/province [17] 0 0
Breda
Country [18] 0 0
Netherlands
State/province [18] 0 0
Roosendaal
Country [19] 0 0
Netherlands
State/province [19] 0 0
Rotterdam
Country [20] 0 0
Netherlands
State/province [20] 0 0
Stadskanaal
Country [21] 0 0
Netherlands
State/province [21] 0 0
Utrecht
Country [22] 0 0
Poland
State/province [22] 0 0
Gdansk
Country [23] 0 0
Poland
State/province [23] 0 0
Lublin
Country [24] 0 0
Poland
State/province [24] 0 0
Mosina k/Poznania
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Kazan
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Russian Federation
State/province [28] 0 0
St. Petersburg
Country [29] 0 0
South Africa
State/province [29] 0 0
Free State
Country [30] 0 0
South Africa
State/province [30] 0 0
Gauteng
Country [31] 0 0
South Africa
State/province [31] 0 0
Kwa-Zulu Natal
Country [32] 0 0
South Africa
State/province [32] 0 0
Mpumalanga
Country [33] 0 0
South Africa
State/province [33] 0 0
Western Cape
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Chichester
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Darlington
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Glasgow
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Plymouth
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Solihull

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy of TAK-583, once daily (QD), in
relieving pain in subjects with postherpetic neuralgia.
Trial website
https://clinicaltrials.gov/show/NCT00377598
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
VP Clinical Science
Address 0 0
Takeda Global Research & Development Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications