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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00545740
Ethics application status
Date submitted
16/10/2007
Date registered
17/10/2007
Date last updated
14/06/2021

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
Timepoint [1] 0 0
Up to 104 weeks
Secondary outcome [1] 0 0
Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis
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
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
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
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
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
Sex
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
28/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2012
Sample size
Target
Accrual to date
Final
590
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
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Tennessee
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Texas
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Colombia
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Barranquilla
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Colombia
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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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Brittany
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France
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Normandy
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France
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Paris
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France
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Picardie
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France
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Provence-Alpes-Côte d'Azur
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France
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Provence-Alpes-Côte-d'Azur
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France
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Rhone-Alpes
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Lille
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Kerala
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Punjab
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India
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Rajasthan
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India
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Tamil Nadu
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India
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West Bengal
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India
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Ahmedabad
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India
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Pune
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India
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Secunderabad
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Israel
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Afula
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Petah-Tikva
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Israel
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Rechovot
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Israel
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Zerifin
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
State/province [57] 0 0
Dunedin
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New Zealand
State/province [58] 0 0
Hamilton
Country [59] 0 0
New Zealand
State/province [59] 0 0
Tauranga
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Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Palma de Mallorca
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Spain
State/province [62] 0 0
San Sebastian
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Spain
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Valencia
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Sweden
State/province [64] 0 0
Goteborg
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Sweden
State/province [65] 0 0
Linköping
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Sweden
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Stockholm
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Sweden
State/province [67] 0 0
Uppsala
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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/study/NCT00545740
Trial related presentations / publications
Raskin JB, Kamm MA, Jamal MM, Marquez J, Melzer E, Schoen RE, Szaloki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00545740