Prevention of Recurrence of Diverticulitis

Diverticulitis Clinical Trial

— PREVENT2  

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: NCT00545103
• Other study ID #: SPD476-314
• Secondary ID: 2007-004896-20
• Status: Completed
• Phase: Phase 3
• Start date: December 6, 2007
• Est. completion date: November 28, 2011

Study information

• Verified date: May 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: 592
• Est. completion date: November 28, 2011
• Est. primary completion date: November 28, 2011
• 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, MMX™ mesalazine, 1.2g extended release tablet
SPD476 1.2g administered Once Daily (QD)
• SPD476, MMX™ mesalazine, 2.4g extended release tablet
SPD476 2.4g administered Once Daily (QD)
• SPD476, MMX™ mesalazine, 4.8g extended release tablet
SPD476 4.8g administered Once Daily (QD)
• Placebo
Placebo administered Once Daily (QD)

Locations

Country	Name	City	State
Brazil	Unidade Integrada de Gastroenterologia UNIGASTRO	Campinas	SP
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.	Goiania	GO
Brazil	Universidade Federal de Juiz de Fora	Juiz de Fora	MG
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital Sao Lucas PUCRS	Porto Alegre	RS
Brazil	Hospital Universitário Clementino Fraga Filho	Rio de Janeiro	RJ
Brazil	Hospital Universitario Pedro Ernesto	Rio de Janeiro
Brazil	Fundacao Universidade Federal do Rio Grande - Hopsital Universitario	Rio Grande	RS
Brazil	Irmandade da Santa Casa de Misericordia de Santos	Santos	Sao Paolo
Brazil	Centro de Pesquisas Clinicas- CPCLIN	Sao Paulo
Canada	Corunna Medical Research Centre	Corunna	Ontario
Canada	Hotel-Dieu de Levis	Levis	Quebec
Canada	Omnispec Clinical Research	Mirabel	Quebec
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Gastroenterology Centre	Pointe-Claire	Quebec
Canada	Q&T Research	Sherbrooke	Quebec
Canada	Topsail Road Medical Clinic	St John's	Newfoundland and Labrador
Canada	Cleveland Clinic Canada	Toronto	Ontario
Canada	Liver and Intestinal Research Centre	Vancouver	British Columbia
Finland	Suomen Terveystalo Oyj	Jyvaskyla
Finland	Kuopio University Hospital	Kuopio
Finland	Päijat-Häme Central Hospital	Lahti
Finland	Oulu University Hospital	Oulu
Finland	Vaasa Central Hospital	Vaasa
Germany	Synexus ClinPharm GmbH Berlin	Berlin	Berlin (Hellersdorf)
Germany	Synexus ClinPharm International GmbH	Bochum
Germany	Synexus ClinPharm International GmbH	Frankfurt
Germany	Synexus ClinPharm International GmbH	Görlitz
Germany	Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne	Herne	Nord-Rhein-Wesfalen
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Synexus ClinPharm International GmbH	Leipzig
Germany	Synexus ClinPharm International GmbH	Magdeburg
Germany	Synexus ClinPharm International GmbH	Potsdam
Hungary	Peterfy Hospital, Dept. Of Gastroenterology	Budapest
Hungary	University of Debrecen, 3rd Dept. Of Medicine	Debrecen
Hungary	Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium	Gyula
Hungary	Kaposi Mór Teaching Hospital	Kaposvár
Hungary	Karolina Hospital, Dept. of Internal Medicine and Gastroenterology	Mosonmagyaróvár
Hungary	Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat	Vác
Italy	Ospedale Valduce	Como
Italy	Ospedale Fatebenefratelli ed Oftalmico	Milano
Italy	Universita degli Studi di Padova	Padova
Italy	U.O. di Gastroenterologia ed Endoscopia digestiva Torre delle Medicine Azienda Ospedaliera di Parma	Parma
Italy	Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina	Pavia
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma
Italy	Policlinico Univeritario A Gemelli	Roma
Italy	Policlinico Univeritario A. Gemelli	Roma
Italy	San Camillo Forlanini	Roma
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	St. Jans Gashuis	Weert
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Spitalul Clinic "Dr. I. Cantacuzino"	Bucharest
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucharest
Romania	Centrul Medical Galenus	Targu Mures
Romania	CMI de Gastroenterologie Dobru Daniela	Targu Mures	Mures
Romania	Cabinet Particular Policlinic Algomed SRL	Timisoara
Romania	Policlinica "Dr. Citu" SRL	Timisoara
South Africa	Universitas Hospital	Bloemfontein
South Africa	Harold Bloch	Cape Town
South Africa	Kingsbury Hospital	Cape Town
South Africa	Louis Leipoldt Medical Centre	Cape Town
South Africa	Panorama Medi-Clinic	Cape Town
South Africa	Panorama Medi-Clinic	Cape Town	Western Cape
South Africa	Chelmsford Medical Centre 2	Durban
South Africa	Parklands Medical Centre	Durban
South Africa	Johannesburg General Hospital	Johannesburg
South Africa	Linksfield Park Clinic	Johannesburg
South Africa	Milpark Hospital	Johannesburg
South Africa	Kloof Medi-Clinic	Pretoria
United States	Maryland Clinical Trials	Annapolis	Maryland
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Northwest Gastroenerology Associates	Bellevue	Washington
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Birmingham Gastroenterology Associates, PC	Birmingham	Alabama
United States	Madeleine DuPree, MD	Boynton Beach	Florida
United States	Clinsearch, LLC	Chattanooga	Tennessee
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Gastrointestinal Clinical of Quad Cities	Davenport	Iowa
United States	Digestive Specialists Inc.	Dayton	Ohio
United States	Cumberland Research Associates	Fayetteville	North Carolina
United States	AMH Feasterville Family Health Care Center	Feasterville	Pennsylvania
United States	Digestive and Liver Disease Specialists	Garden Grove	California
United States	Memphis Gastroenterology Group, PC	Germantown	Tennessee
United States	LeBauer Research Associates, PA	Greensboro	North Carolina
United States	Palmetto Research LLC	Hialeah	Florida
United States	Mark Lamet, MD	Hollywood	Florida
United States	Mid Atlantic Medical Research Centers	Hollywood	Maryland
United States	Houston Endoscopy and Research Center	Houston	Texas
United States	Alabama Digestive Disorders Center, PC	Huntsville	Alabama
United States	Medical Affiliated Research Center, Inc	Huntsville	Alabama
United States	Gastrointestinal Associates, PA	Jackson	Mississippi
United States	Clinical Research of the Rockies	Lafayette	Colorado
United States	NY Center for Clinical Research	Lake Success	New York
United States	High Desert Gastroenterology, Inc.	Lancaster	California
United States	Arapahoe Gastroenterology, PC	Littleton	Colorado
United States	VA Long Beach Healthcare System	Long Beach	California
United States	Charm City Research, LLC	Lutherville	Maryland
United States	Digestive Disease Consultants	Maitland	Florida
United States	Atlanta Gastroenterology Associates	Marietta	Georgia
United States	Center for Digestive & Liver Diseases, Inc	Mexico	Missouri
United States	Miami Research Associates	Miami	Florida
United States	University of Miami	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Sunflower Medical Group	Mission	Kansas
United States	Physician Research Options	Murray	Utah
United States	United Medical Research	New Smyrna Beach	Florida
United States	Concorde Medical Group	New York	New York
United States	CA Physicians Research Alliance	Oceanside	California
United States	Digestive Disorders Center	Pittsburgh	Pennsylvania
United States	Shah Associates, LLC	Prince Frederick	Maryland
United States	Wake Research Associates	Raleigh	North Carolina
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Hidalgo Clinical Research	San Antonio	Texas
United States	Digestive Care Medical Center	San Carlos	California
United States	Rider Research Group	San Francisco	California
United States	Huntington Medical Foundation	San Marino	California
United States	Granite Peaks Gastroenterology	Sandy	Utah
United States	Seattle Gastroenterology Associates	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	West Wind'r Research & Development	Tampa	Florida
United States	Kansas Medical Clinic	Topeka	Kansas
United States	Litchfield County Gastroenterology Associates, LLC	Torrington	Connecticut
United States	Center for Digestive Health	Troy	Michigan
United States	Genova Clinical Research	Tucson	Arizona
United States	The Gastroenterology Group of South Jersey	Vineland	New Jersey
United States	Digestive Health Specialists	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Finland,  Germany,  Hungary,  Italy,  Netherlands,  Romania,  South Africa, 

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 Are 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