Clinical trial NCT00545103: Prevention of Recurrence of Diverticulitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diverticulitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Percent of Subjects Without Recurrence of Diverticulitis
timeFrame: up to 104 Weeks
Secondary outcomes:
measure: Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis
timeFrame: up to 104 weeks
measure: Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
timeFrame: up to 104 Weeks
measure: Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
timeFrame: up to 104 weeks
measure: Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
timeFrame: up to 104 weeks
measure: Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
timeFrame: up to 104 weeks
measure: Percent of Subjects Requiring Surgery for Diverticulitis
timeFrame: up to 104 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastroenterology Associates, PC
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc
state: Alabama
city: Huntsville
country: United States
facility: Alabama Digestive Disorders Center, PC
state: Alabama
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Garden Grove
country: United States
facility: Digestive and Liver Disease Specialists
state: California
city: Lancaster
country: United States
facility: High Desert Gastroenterology, Inc.
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Oceanside
country: United States
facility: CA Physicians Research Alliance
state: California
city: San Carlos
country: United States
facility: Digestive Care Medical Center
state: California
city: San Francisco
country: United States
facility: Rider Research Group
state: California
city: San Marino
country: United States
facility: Huntington Medical Foundation
state: California
city: Lafayette
country: United States
facility: Clinical Research of the Rockies
state: Colorado
city: Littleton
country: United States
facility: Arapahoe Gastroenterology, PC
state: Colorado
city: Torrington
country: United States
facility: Litchfield County Gastroenterology Associates, LLC
state: Connecticut
city: Boynton Beach
country: United States
facility: Madeleine DuPree, MD
state: Florida
city: Hialeah
country: United States
facility: Palmetto Research LLC
state: Florida
city: Hollywood
country: United States
facility: Mark Lamet, MD
state: Florida
city: Maitland
country: United States
facility: Digestive Disease Consultants
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: New Smyrna Beach
country: United States
facility: United Medical Research
state: Florida
city: Tampa
country: United States
facility: West Wind'r Research & Development
state: Florida
city: Marietta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Davenport
country: United States
facility: Gastrointestinal Clinical of Quad Cities
state: Iowa
city: Mission
country: United States
facility: Sunflower Medical Group
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Maryland Clinical Trials
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Hollywood
country: United States
facility: Mid Atlantic Medical Research Centers
state: Maryland
city: Lutherville
country: United States
facility: Charm City Research, LLC
state: Maryland
city: Prince Frederick
country: United States
facility: Shah Associates, LLC
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Jackson
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Mexico
country: United States
facility: Center for Digestive & Liver Diseases, Inc
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Vineland
country: United States
facility: The Gastroenterology Group of South Jersey
state: New Jersey
city: Lake Success
country: United States
facility: NY Center for Clinical Research
state: New York
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Research Associates, PA
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Digestive Specialists Inc.
state: Ohio
city: Feasterville
country: United States
facility: AMH Feasterville Family Health Care Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Digestive Disorders Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Clinsearch, LLC
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Houston
country: United States
facility: Houston Endoscopy and Research Center
state: Texas
city: San Antonio
country: United States
facility: Hidalgo Clinical Research
state: Texas
city: Murray
country: United States
facility: Physician Research Options
state: Utah
city: Sandy
country: United States
facility: Granite Peaks Gastroenterology
state: Utah
city: Bellevue
country: United States
facility: Northwest Gastroenerology Associates
state: Washington
city: Seattle
country: United States
facility: Seattle Gastroenterology Associates
state: Washington
city: Goiania
country: Brazil
facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
state: GO
city: Juiz de Fora
country: Brazil
facility: Universidade Federal de Juiz de Fora
state: MG
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas PUCRS
state: RS
city: Rio Grande
country: Brazil
facility: Fundacao Universidade Federal do Rio Grande - Hopsital Universitario
state: RS
city: Santos
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Santos
state: Sao Paolo
city: Campinas
country: Brazil
facility: Unidade Integrada de Gastroenterologia UNIGASTRO
state: SP
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Pedro Ernesto
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisas Clinicas- CPCLIN
city: Vancouver
country: Canada
facility: Liver and Intestinal Research Centre
state: British Columbia
city: St John's
country: Canada
facility: Topsail Road Medical Clinic
state: Newfoundland and Labrador
city: Corunna
country: Canada
facility: Corunna Medical Research Centre
state: Ontario
city: Toronto
country: Canada
facility: Cleveland Clinic Canada
state: Ontario
city: Levis
country: Canada
facility: Hotel-Dieu de Levis
state: Quebec
city: Mirabel
country: Canada
facility: Omnispec Clinical Research
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Pointe-Claire
country: Canada
facility: Gastroenterology Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research
state: Quebec
city: Jyvaskyla
country: Finland
facility: Suomen Terveystalo Oyj
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Lahti
country: Finland
facility: Päijat-Häme Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
city: Berlin
country: Germany
facility: Synexus ClinPharm GmbH Berlin
state: Berlin (Hellersdorf)
city: Herne
country: Germany
facility: Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne
state: Nord-Rhein-Wesfalen
city: Bochum
country: Germany
facility: Synexus ClinPharm International GmbH
city: Frankfurt
country: Germany
facility: Synexus ClinPharm International GmbH
city: Görlitz
country: Germany
facility: Synexus ClinPharm International GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Synexus ClinPharm International GmbH
city: Magdeburg
country: Germany
facility: Synexus ClinPharm International GmbH
city: Potsdam
country: Germany
facility: Synexus ClinPharm International GmbH
city: Budapest
country: Hungary
facility: Peterfy Hospital, Dept. Of Gastroenterology
city: Debrecen
country: Hungary
facility: University of Debrecen, 3rd Dept. Of Medicine
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
city: Kaposvár
country: Hungary
facility: Kaposi Mór Teaching Hospital
city: Mosonmagyaróvár
country: Hungary
facility: Karolina Hospital, Dept. of Internal Medicine and Gastroenterology
city: Vác
country: Hungary
facility: Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat
city: Como
country: Italy
facility: Ospedale Valduce
city: Milano
country: Italy
facility: Ospedale Fatebenefratelli ed Oftalmico
city: Padova
country: Italy
facility: Universita degli Studi di Padova
city: Parma
country: Italy
facility: U.O. di Gastroenterologia ed Endoscopia digestiva Torre delle Medicine Azienda Ospedaliera di Parma
city: Pavia
country: Italy
facility: Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Roma
country: Italy
facility: San Camillo Forlanini
city: Roma
country: Italy
facility: Policlinico Univeritario A Gemelli
city: Roma
country: Italy
facility: Policlinico Univeritario A. Gemelli
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Weert
country: Netherlands
facility: St. Jans Gashuis
city: Targu Mures
country: Romania
facility: CMI de Gastroenterologie Dobru Daniela
state: Mures
city: Bucharest
country: Romania
facility: Spitalul Clinic "Dr. I. Cantacuzino"
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Targu Mures
country: Romania
facility: Centrul Medical Galenus
city: Timisoara
country: Romania
facility: Cabinet Particular Policlinic Algomed SRL
city: Timisoara
country: Romania
facility: Policlinica "Dr. Citu" SRL
city: Cape Town
country: South Africa
facility: Panorama Medi-Clinic
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Universitas Hospital
city: Cape Town
country: South Africa
facility: Harold Bloch
city: Cape Town
country: South Africa
facility: Panorama Medi-Clinic
city: Cape Town
country: South Africa
facility: Louis Leipoldt Medical Centre
city: Cape Town
country: South Africa
facility: Kingsbury Hospital
city: Durban
country: South Africa
facility: Parklands Medical Centre
city: Durban
country: South Africa
facility: Chelmsford Medical Centre 2
city: Johannesburg
country: South Africa
facility: Milpark Hospital
city: Johannesburg
country: South Africa
facility: Linksfield Park Clinic
city: Johannesburg
country: South Africa
facility: Johannesburg General Hospital
city: Pretoria
country: South Africa
facility: Kloof Medi-Clinic
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.