Clinical trial NCT00545740: 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: 590
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 Were 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: Litchfield Park
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Chula Vista
country: United States
facility: GW Research
state: California
city: Monterey
country: United States
facility: Monterey Bay GI Research Institute, Inc
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga C. Trials
state: California
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research
state: California
city: Torrance
country: United States
facility: Torrance Clinical Research
state: California
city: Thornton
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
city: Boynton Beach
country: United States
facility: ZASA Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Port Orange
country: United States
facility: Accord Clinic Research, LLC
state: Florida
city: Tampa
country: United States
facility: Florida Medical Clinic/Tampa Clinical Trials
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Anderson
country: United States
facility: Saint John's Research Institute
state: Indiana
city: Clive
country: United States
facility: Digestive & Liver Disease Consultants
state: Iowa
city: Metairie
country: United States
facility: New Orleans Research Institute
state: Louisiana
city: Baltimore
country: United States
facility: Digestive Disease Associates
state: Maryland
city: Towson
country: United States
facility: Endoscopic Microsurgery Associates, PA
state: Maryland
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Marlton
country: United States
facility: South Jersey Gastroenterology, P.A.
state: New Jersey
city: Ocean City
country: United States
facility: Howard Guss, DO
state: New Jersey
city: Passaic
country: United States
facility: New Jersey Physicians, LLC
state: New Jersey
city: Voorhees
country: United States
facility: Allied Gastrointestinal Associates, P.A.
state: New Jersey
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: New York
country: United States
facility: Research Associates of New York
state: New York
city: Greensboro
country: United States
facility: Vital Research
state: North Carolina
city: Canton
country: United States
facility: Gastroenterology Specialists, Inc
state: Ohio
city: Chattanooga
country: United States
facility: Memorial Research Center
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates Clinical Research
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Fort Worth
country: United States
facility: Harris Methodist Fort Worth Hospital
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Stone Oak Research Foundation
state: Texas
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc. - Clinical Research Center
state: Wisconsin
city: Lanus
country: Argentina
facility: CIMEL
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto Gamma
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Bocalandro
city: Buenos Aires
country: Argentina
facility: Hospital Heroes de Malvinas
city: Buenos Aires
country: Argentina
facility: GEDYT
city: Buenos Aires
country: Argentina
facility: Sanatorio Guemes
city: Santa Fe
country: Argentina
facility: Cibic S.A.
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital (Melb) LTD
state: Victoria
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Camperdown
country: Australia
facility: Royal Prince Albert Hospital
city: Frankston
country: Australia
facility: Frankston Private
city: Frankston
country: Australia
facility: Bayside Gastroenterology
city: Fremantle
country: Australia
facility: Fremantle Hospital
city: Barranquilla
country: Colombia
facility: Ugasend S.A
city: Bogota
country: Colombia
facility: Clinica Colsinatas SA
city: Bogota
country: Colombia
facility: FOQUS, Centro de Investigacion Clinica
city: Bogota
country: Colombia
facility: Fundacion Clinica Abood Shaio
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Medellin
country: Colombia
facility: Clinica Las Americas
city: Strasbourg
country: France
facility: CHU de Strasbourg
state: Alsace
city: Nantes
country: France
facility: Hepato Gastro Enterology
state: Brittany
city: Rouen
country: France
facility: Hopital Charles Nicolle
state: Normandy
city: Clichy
country: France
facility: Hopital Beaujon
state: Paris
city: Saint Quentin
country: France
facility: Cabinet de Gastro-enterologie du Dr Alain Thevenin
state: Picardie
city: Nice
country: France
facility: Hopital I'Archet
state: Provence-Alpes-Côte d'Azur
city: Marseille
country: France
facility: Clinique Bouchard
state: Provence-Alpes-Côte-d'Azur
city: Grenoble
country: France
facility: CHU de Grenoble
state: Rhone-Alpes
city: Lille
country: France
facility: Cabinet du Dr Olivier Delette
city: Paris
country: France
facility: Dr Michel Regensberg
city: Calicut
country: India
facility: Baby Memorial Hospital
state: Kerala
city: Cochin
country: India
facility: Lakeshore Hospital & Research Centre Ltd
state: Kerala
city: Trivandrum
country: India
facility: Sree Gokulam Medical College and Research Foundation
state: Kerala
city: Ludhiana
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Jaipur
country: India
facility: S R Kalla Memorial Hospital
state: Rajasthan
city: Chennai
country: India
facility: Aceer
state: Tamil Nadu
city: Kolkata
country: India
facility: Institute of Postgraduate Medical Education and Research
state: West Bengal
city: Ahmedabad
country: India
facility: Brahmin Mitra Mandal Society
city: Pune
country: India
facility: Ruby Hall Clinic
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
city: Afula
country: Israel
facility: Emek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Centre
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein-Karem Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Centre
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Takapuna
country: New Zealand
facility: Shakespeare Specialist Group
state: Auckland
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: CURT Medical Trials Trust Board
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Barcelona
country: Spain
facility: Hospital Valle de Hebron
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: San Sebastian
country: Spain
facility: Hospital de Donostia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Goteborg
country: Sweden
facility: University Hospital/Eastern Hospital
city: Linköping
country: Sweden
facility: University Hospital Linköping
city: Stockholm
country: Sweden
facility: VO Internmedicin
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Uppsala
country: Sweden
facility: Kirurgkliniken
city: Norwich
country: United Kingdom
facility: Norfolk/Norwich University Hospital
state: East Anglia
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
state: London
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: London
country: United Kingdom
facility: Imperial College London
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.