Prevention of Recurrence of Diverticulitis

Diverticulitis Clinical Trial

— PREVENT1  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545740
• Other study ID #: SPD476-313
• Secondary ID: 2007-004895-37
• Status: Completed
• Phase: Phase 3
• Start date: November 28, 2007
• Est. completion date: March 5, 2012

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: March 5, 2012
• Est. primary completion date: March 5, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Diverticulitis
• Recurrence

Intervention

Drug:
• SPD476 (1.2g)
1.2g SPD476 once daily (QD) orally
• SPD476 (2.4 g)
2.4g SPD476 QD orally
• SPD476 (4.8 g)
4.8g SPD476 QD orally
• Placebo
QD orally

Locations

Country	Name	City	State
Argentina	GEDYT	Buenos Aires
Argentina	Hospital Bocalandro	Buenos Aires
Argentina	Hospital Heroes de Malvinas	Buenos Aires
Argentina	Sanatorio Guemes	Buenos Aires
Argentina	CIMEL	Lanus	Buenos Aires
Argentina	Instituto Gamma	Rosario	Santa Fe
Argentina	Cibic S.A.	Santa Fe
Australia	Royal Adelaide Hospital	Adelaide
Australia	Ballarat Base Hospital	Ballarat	Victoria
Australia	Royal Prince Albert Hospital	Camperdown
Australia	Bayside Gastroenterology	Frankston
Australia	Frankston Private	Frankston
Australia	Fremantle Hospital	Fremantle
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	St Vincent's Hospital (Melb) LTD	Melbourne	Victoria
Colombia	Ugasend S.A	Barranquilla
Colombia	Clinica Colsinatas SA	Bogota
Colombia	FOQUS, Centro de Investigacion Clinica	Bogota
Colombia	Fundacion Clinica Abood Shaio	Bogota
Colombia	Hospital Universitario San Ignacio	Bogota
Colombia	Clinica Las Americas	Medellin
France	Hopital Beaujon	Clichy	Paris
France	CHU de Grenoble	Grenoble	Rhone-Alpes
France	Cabinet du Dr Olivier Delette	Lille
France	Clinique Bouchard	Marseille	Provence-Alpes-Côte-d'Azur
France	Hepato Gastro Enterology	Nantes	Brittany
France	Hopital I'Archet	Nice	Provence-Alpes-Côte d'Azur
France	Dr Michel Regensberg	Paris
France	Hopital Charles Nicolle	Rouen	Normandy
France	Cabinet de Gastro-enterologie du Dr Alain Thevenin	Saint Quentin	Picardie
France	CHU de Strasbourg	Strasbourg	Alsace
India	Brahmin Mitra Mandal Society	Ahmedabad
India	Baby Memorial Hospital	Calicut	Kerala
India	Aceer	Chennai	Tamil Nadu
India	Lakeshore Hospital & Research Centre Ltd	Cochin	Kerala
India	S R Kalla Memorial Hospital	Jaipur	Rajasthan
India	Institute of Postgraduate Medical Education and Research	Kolkata	West Bengal
India	Dayanand Medical College and Hospital	Ludhiana	Punjab
India	Ruby Hall Clinic	Pune
India	Krishna Institute of Medical Sciences	Secunderabad
India	Sree Gokulam Medical College and Research Foundation	Trivandrum	Kerala
Israel	Emek Medical Center	Afula
Israel	Barzilai Medical Centre	Ashkelon
Israel	Soroka Medical Center	Beer Sheva
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Ein-Karem Medical Center	Jerusalem
Israel	Meir Medical Centre	Kfar-Saba
Israel	Rabin Medical Center	Petah-Tikva
Israel	Kaplan Medical Center	Rechovot
Israel	The Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Chaim Sheba Medical Center	Tel Hashomer
Israel	Assaf Harofeh Medical Center	Zerifin
New Zealand	Auckland City Hospital	Auckland
New Zealand	CURT Medical Trials Trust Board	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Shakespeare Specialist Group	Takapuna	Auckland
New Zealand	Tauranga Hospital	Tauranga
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Valle de Hebron	Barcelona
Spain	Hospital Son Dureta	Palma de Mallorca
Spain	Hospital de Donostia	San Sebastian
Spain	Hospital General Universitario de Valencia	Valencia
Sweden	University Hospital/Eastern Hospital	Goteborg
Sweden	University Hospital Linköping	Linköping
Sweden	Danderyd Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	VO Internmedicin	Stockholm
Sweden	Kirurgkliniken	Uppsala
United Kingdom	St Mark's Hospital	Harrow	London
United Kingdom	Chelsea & Westminster Hospital	London
United Kingdom	Imperial College London	London
United Kingdom	King's College Hospital	London
United Kingdom	Norfolk/Norwich University Hospital	Norwich	East Anglia
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Saint John's Research Institute	Anderson	Indiana
United States	Digestive Disease Associates	Baltimore	Maryland
United States	ZASA Clinical Research	Boynton Beach	Florida
United States	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Gastroenterology Specialists, Inc	Canton	Ohio
United States	Memorial Research Center	Chattanooga	Tennessee
United States	GW Research	Chula Vista	California
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Digestive & Liver Disease Consultants	Clive	Iowa
United States	Regional Clinical Research	Endwell	New York
United States	Harris Methodist Fort Worth Hospital	Fort Worth	Texas
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	Vital Research	Greensboro	North Carolina
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Jefferson City Medical Group	Jefferson City	Missouri
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Gastroenterology Associates Clinical Research	Kingsport	Tennessee
United States	Dedicated Clinical Research	Litchfield Park	Arizona
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia
United States	South Jersey Gastroenterology, P.A.	Marlton	New Jersey
United States	New Orleans Research Institute	Metairie	Louisiana
United States	Aurora Advanced Healthcare, Inc. - Clinical Research Center	Milwaukee	Wisconsin
United States	Monterey Bay GI Research Institute, Inc	Monterey	California
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Research Associates of New York	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Howard Guss, DO	Ocean City	New Jersey
United States	Compass Research	Orlando	Florida
United States	New Jersey Physicians, LLC	Passaic	New Jersey
United States	Accord Clinic Research, LLC	Port Orange	Florida
United States	Rancho Cucamonga C. Trials	Rancho Cucamonga	California
United States	Clinical Trials Research	Roseville	California
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Stone Oak Research Foundation	San Antonio	Texas
United States	Medical Associates Research	San Diego	California
United States	Florida Medical Clinic/Tampa Clinical Trials	Tampa	Florida
United States	Rocky Mountain Gastroenterology Associates	Thornton	Colorado
United States	Torrance Clinical Research	Torrance	California
United States	Endoscopic Microsurgery Associates, PA	Towson	Maryland
United States	Allied Gastrointestinal Associates, P.A.	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Colombia,  France,  India,  Israel,  New Zealand,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 104 weeks
Secondary	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.	Up to 104 weeks
Secondary	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.	Up to 104 weeks
Secondary	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.	Up to 104 weeks
Secondary	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.	Up to 104 weeks
Secondary	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.	Up to 104 weeks
Secondary	Percent of Subjects Requiring Surgery for Diverticulitis		Up to 104 weeks