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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00545740




Registration number
NCT00545740
Ethics application status
Date submitted
16/10/2007
Date registered
17/10/2007
Date last updated
12/06/2014

Titles & IDs
Public title
Prevention of Recurrence of Diverticulitis
Scientific title
A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.
Secondary ID [1] 0 0
2007-004895-37
Secondary ID [2] 0 0
SPD476-313
Universal Trial Number (UTN)
Trial acronym
PREVENT1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diverticulitis 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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SPD476 (1.2g)
Treatment: Drugs - SPD476 (2.4 g)
Treatment: Drugs - SPD476 (4.8 g)
Treatment: Drugs - Placebo

Experimental: SPD476 (1.2 g) -

Experimental: SPD476 (2.4 g) -

Experimental: SPD476 (4.8 g) -

Placebo Comparator: Placebo -


Treatment: Drugs: SPD476 (1.2g)
1.2g SPD476 once daily (QD) orally

Treatment: Drugs: SPD476 (2.4 g)
2.4g SPD476 QD orally

Treatment: Drugs: SPD476 (4.8 g)
4.8g SPD476 QD orally

Treatment: Drugs: Placebo
QD orally

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

Outcomes
Primary outcome [1] 0 0
Percent of Subjects Without Recurrence of Diverticulitis - Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Timepoint [1] 0 0
Up to 104 weeks
Secondary outcome [1] 0 0
Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis - CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.
Timepoint [1] 0 0
Up to 104 weeks
Secondary outcome [2] 0 0
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive - A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Timepoint [2] 0 0
Up to 104 weeks
Secondary outcome [3] 0 0
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative - A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Timepoint [3] 0 0
Up to 104 weeks
Secondary outcome [4] 0 0
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive - A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Timepoint [4] 0 0
Up to 104 weeks
Secondary outcome [5] 0 0
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative - A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.
Timepoint [5] 0 0
Up to 104 weeks
Secondary outcome [6] 0 0
Percent of Subjects Requiring Surgery for Diverticulitis
Timepoint [6] 0 0
Up to 104 weeks

Eligibility
Key inclusion criteria
1. Males and females =>18yrs of age.

2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG
(human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any
applicable contraceptive requirements of the protocol.

3. An episode of acute diverticulitis that resolved without colonic resection.

4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at
least three diverticula noted.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous colorectal surgery, including surgical intervention for diverticular disease
(with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)

2. Active peptic ulcer disease

3. History of or current presence of inflammatory bowel disease (IBD)

4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication

5. Allergy or hypersensitivity to aspirin or related compounds

6. Allergy to radiologic contrast agents

7. Use of another Investigational product within 30 days of Baseline

8. Use of antibiotic therapy within 4 weeks of Baseline

9. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well
as drugs active at the 5HT-receptor or anti-spasmodic agents

10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal
steroids is acceptable

11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except
for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis

12. History of alcohol or other substance abuse within the previous year

13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to
Baseline

14. Females who are lactating

Study design
Purpose of the study
Prevention
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 administering the treatment/s
The people assessing the outcomes
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
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)
ACT,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [3] 0 0
St Vincent's Hospital (Melb) LTD - Melbourne
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Royal Prince Albert Hospital - Camperdown
Recruitment hospital [6] 0 0
Frankston Private - Frankston
Recruitment hospital [7] 0 0
Bayside Gastroenterology - Frankston
Recruitment hospital [8] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
2050 - Camperdown
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
VIC 3199 - Frankston
Recruitment postcode(s) [8] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
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Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
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Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Santa Fe
Country [24] 0 0
Colombia
State/province [24] 0 0
Barranquilla
Country [25] 0 0
Colombia
State/province [25] 0 0
Bogota
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Colombia
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Medellin
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France
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Alsace
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France
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Brittany
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France
State/province [29] 0 0
Normandy
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France
State/province [30] 0 0
Paris
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France
State/province [31] 0 0
Picardie
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France
State/province [32] 0 0
Provence-Alpes-Côte d'Azur
Country [33] 0 0
France
State/province [33] 0 0
Provence-Alpes-Côte-d'Azur
Country [34] 0 0
France
State/province [34] 0 0
Rhone-Alpes
Country [35] 0 0
France
State/province [35] 0 0
Lille
Country [36] 0 0
India
State/province [36] 0 0
Kerala
Country [37] 0 0
India
State/province [37] 0 0
Punjab
Country [38] 0 0
India
State/province [38] 0 0
Rajasthan
Country [39] 0 0
India
State/province [39] 0 0
Tamil Nadu
Country [40] 0 0
India
State/province [40] 0 0
Gujarat
Country [41] 0 0
India
State/province [41] 0 0
Kolkatta
Country [42] 0 0
India
State/province [42] 0 0
Pune
Country [43] 0 0
India
State/province [43] 0 0
Secunderabad
Country [44] 0 0
Israel
State/province [44] 0 0
Afula
Country [45] 0 0
Israel
State/province [45] 0 0
Ashkelon
Country [46] 0 0
Israel
State/province [46] 0 0
Beer Sheva
Country [47] 0 0
Israel
State/province [47] 0 0
Haifa
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Israel
State/province [48] 0 0
Jerusalem
Country [49] 0 0
Israel
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Kfar-Saba
Country [50] 0 0
Israel
State/province [50] 0 0
Petah-Tikva
Country [51] 0 0
Israel
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Rechovot
Country [52] 0 0
Israel
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Tel Aviv
Country [53] 0 0
Israel
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Tel Hashomer
Country [54] 0 0
Israel
State/province [54] 0 0
Zerifin
Country [55] 0 0
New Zealand
State/province [55] 0 0
Auckland
Country [56] 0 0
New Zealand
State/province [56] 0 0
Christchurch
Country [57] 0 0
New Zealand
State/province [57] 0 0
Dunedin
Country [58] 0 0
New Zealand
State/province [58] 0 0
Hamilton
Country [59] 0 0
New Zealand
State/province [59] 0 0
Tauranga
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Palma de Mallorca
Country [62] 0 0
Spain
State/province [62] 0 0
San Sebastian
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
Sweden
State/province [64] 0 0
Goteborg
Country [65] 0 0
Sweden
State/province [65] 0 0
Linköping
Country [66] 0 0
Sweden
State/province [66] 0 0
Stockholm
Country [67] 0 0
Sweden
State/province [67] 0 0
Uppsala
Country [68] 0 0
United Kingdom
State/province [68] 0 0
East Anglia
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence
of diverticulitis.
Trial website
https://clinicaltrials.gov/show/NCT00545740
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof. Michael Kamm
Address 0 0
St. Vincent's Hospital-Manhattan
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