Prevention of Recurrence of Diverticulitis
PREVENT1
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.
2 other identifiers
interventional
590
11 countries
121
Brief Summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2007
Typical duration for phase_3
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 17, 2007
CompletedStudy Start
First participant enrolled
November 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2012
CompletedResults Posted
Study results publicly available
January 25, 2013
CompletedJune 14, 2021
June 1, 2021
4.3 years
October 16, 2007
December 19, 2012
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis
Up to 104 weeks
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Up to 104 weeks
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Up to 104 weeks
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Up to 104 weeks
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Up to 104 weeks
- +1 more secondary outcomes
Study Arms (4)
SPD476 (1.2 g)
EXPERIMENTALSPD476 (2.4 g)
EXPERIMENTALSPD476 (4.8 g)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
1.2g SPD476 once daily (QD) orally
Eligibility Criteria
You may qualify if:
- Males and females =\>18yrs of age.
- 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.
- An episode of acute diverticulitis that resolved without colonic resection.
- Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted.
You may not qualify if:
- Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
- Active peptic ulcer disease
- History of or current presence of inflammatory bowel disease (IBD)
- Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
- Allergy or hypersensitivity to aspirin or related compounds
- Allergy to radiologic contrast agents
- Use of another Investigational product within 30 days of Baseline
- Use of antibiotic therapy within 4 weeks of Baseline
- 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
- Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
- Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
- History of alcohol or other substance abuse within the previous year
- Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
- Females who are lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (121)
Dedicated Clinical Research
Litchfield Park, Arizona, 85340, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Advanced Clinical Research Institute
Anaheim, California, 92108, United States
GW Research
Chula Vista, California, 91910, United States
Monterey Bay GI Research Institute, Inc
Monterey, California, 93940, United States
Rancho Cucamonga C. Trials
Rancho Cucamonga, California, 91730, United States
Clinical Trials Research
Roseville, California, 95661, United States
Medical Associates Research
San Diego, California, 92123, United States
Torrance Clinical Research
Torrance, California, 90505, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, 80229, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, 06520, United States
ZASA Clinical Research
Boynton Beach, Florida, 33472, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Compass Research
Orlando, Florida, 32806, United States
Accord Clinic Research, LLC
Port Orange, Florida, 32129, United States
Florida Medical Clinic/Tampa Clinical Trials
Tampa, Florida, 33613, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201, United States
Saint John's Research Institute
Anderson, Indiana, 46016, United States
Digestive & Liver Disease Consultants
Clive, Iowa, 50325, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Digestive Disease Associates
Baltimore, Maryland, 21229, United States
Endoscopic Microsurgery Associates, PA
Towson, Maryland, 21204, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
South Jersey Gastroenterology, P.A.
Marlton, New Jersey, 08053, United States
Howard Guss, DO
Ocean City, New Jersey, 07712, United States
New Jersey Physicians, LLC
Passaic, New Jersey, 07055, United States
Allied Gastrointestinal Associates, P.A.
Voorhees Township, New Jersey, 08043, United States
Regional Clinical Research
Endwell, New York, 13760, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Research Associates of New York
New York, New York, 10075, United States
Vital Research
Greensboro, North Carolina, 27408, United States
Gastroenterology Specialists, Inc
Canton, Ohio, 44718, United States
Memorial Research Center
Chattanooga, Tennessee, 37404, United States
Gastroenterology Associates Clinical Research
Kingsport, Tennessee, 37660, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Harris Methodist Fort Worth Hospital
Fort Worth, Texas, 76104, United States
Kelsey-Seybold Clinic
Houston, Texas, 77005, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Stone Oak Research Foundation
San Antonio, Texas, 78258, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Aurora Advanced Healthcare, Inc. - Clinical Research Center
Milwaukee, Wisconsin, 53209, United States
CIMEL
Lanús, Buenos Aires, B1824KAS, Argentina
Instituto Gamma
Rosario, Santa Fe Province, S2000DFD, Argentina
Hospital Bocalandro
Buenos Aires, B1657BHD, Argentina
Hospital Heroes de Malvinas
Buenos Aires, B1722FJN, Argentina
GEDYT
Buenos Aires, C1117AAA, Argentina
Sanatorio Guemes
Buenos Aires, C1180AAX, Argentina
Cibic S.A.
Santa Fe, S2000BCG, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
St Vincent's Hospital (Melb) LTD
Melbourne, Victoria, 3065, Australia
Royal Adelaide Hospital
Adelaide, 5000, Australia
Royal Prince Albert Hospital
Camperdown, 2050, Australia
Frankston Private
Frankston, 3199, Australia
Bayside Gastroenterology
Frankston, VIC 3199, Australia
Fremantle Hospital
Fremantle, 6160, Australia
Ugasend S.A
Barranquilla, Colombia
Clinica Colsinatas SA
Bogotá, Colombia
FOQUS, Centro de Investigacion Clinica
Bogotá, Colombia
Fundacion Clinica Abood Shaio
Bogotá, Colombia
Hospital Universitario San Ignacio
Bogotá, Colombia
Clinica Las Americas
Medellín, Colombia
CHU de Strasbourg
Strasbourg, Alsace, 67200, France
CHU de Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38043, France
Hepato Gastro Enterology
Nantes, Brittany Region, 44033, France
Hopital Charles Nicolle
Rouen, Normandy, 76031, France
Hopital Beaujon
Clichy, Paris, 92118, France
Cabinet de Gastro-enterologie du Dr Alain Thevenin
Saint-Quentin, Picardie, 02100, France
Clinique Bouchard
Marseille, Provence-Alpes-Côte d'Azur Region, 13000, France
Hopital I'Archet
Nice, Provence-Alpes-Côte d'Azur Region, 06200, France
Cabinet du Dr Olivier Delette
Lille, 59000, France
Dr Michel Regensberg
Paris, 75017, France
Baby Memorial Hospital
Calicut, Kerala, 673004, India
Lakeshore Hospital & Research Centre Ltd
Kochi, Kerala, 682304, India
Sree Gokulam Medical College and Research Foundation
Trivandrum, Kerala, 695607, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001, India
S R Kalla Memorial Hospital
Jaipur, Rajasthan, India
Aceer
Chennai, Tamil Nadu, 600020, India
Institute of Postgraduate Medical Education and Research
Kolkata, West Bengal, 700020, India
Brahmin Mitra Mandal Society
Ahmedabad, 380006, India
Ruby Hall Clinic
Pune, 411 001, India
Krishna Institute of Medical Sciences
Secunderabad, 500 003, India
Emek Medical Center
Afula, 18101, Israel
Barzilai Medical Centre
Ashkelon, 78278, Israel
Soroka Medical Center
Beersheba, 84101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 63106, Israel
Hadassah Ein-Karem Medical Center
Jerusalem, Israel
Meir Medical Centre
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Shakespeare Specialist Group
Takapuna, Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
CURT Medical Trials Trust Board
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Hospital Valle de Hebron
Barcelona, 08035, Spain
Hospital Universitario de Bellvitge
Barcelona, 08907, Spain
Hospital de Donostia
Donostia / San Sebastian, 20014, Spain
Hospital Son Dureta
Palma de Mallorca, 07014, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
University Hospital/Eastern Hospital
Gothenburg, 41685, Sweden
University Hospital Linköping
Linköping, 58185, Sweden
VO Internmedicin
Stockholm, 11883, Sweden
Karolinska University Hospital
Stockholm, 17176, Sweden
Danderyd Hospital
Stockholm, 18288, Sweden
Kirurgkliniken
Uppsala, Sweden
Norfolk/Norwich University Hospital
Norwich, East Anglia, NR4 7UY, United Kingdom
St Mark's Hospital
Harrow, London, HA1 3UJ, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Chelsea & Westminster Hospital
London, SW10 9NH, United Kingdom
Imperial College London
London, W12 0NN, United Kingdom
Related Publications (1)
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.
PMID: 25038431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 17, 2007
Study Start
November 28, 2007
Primary Completion
March 5, 2012
Study Completion
March 5, 2012
Last Updated
June 14, 2021
Results First Posted
January 25, 2013
Record last verified: 2021-06