Prevention of Recurrence of Diverticulitis
PREVENT2
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
592
10 countries
131
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 Dec 2007
Typical duration for phase_3
131 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
December 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2011
CompletedResults Posted
Study results publicly available
December 19, 2012
CompletedJune 11, 2021
May 1, 2021
4 years
October 16, 2007
October 11, 2012
June 1, 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 Are 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
SPD476 1.2g administered Once Daily (QD)
SPD476 2.4g administered Once Daily (QD)
SPD476 4.8g administered Once Daily (QD)
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 (131)
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama, 35209, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Medical Affiliated Research Center, Inc
Huntsville, Alabama, 35801, United States
Alabama Digestive Disorders Center, PC
Huntsville, Alabama, 35802, United States
Genova Clinical Research
Tucson, Arizona, 85741, United States
Digestive and Liver Disease Specialists
Garden Grove, California, 92840, United States
High Desert Gastroenterology, Inc.
Lancaster, California, 93534, United States
VA Long Beach Healthcare System
Long Beach, California, 90822, United States
CA Physicians Research Alliance
Oceanside, California, 92083, United States
Digestive Care Medical Center
San Carlos, California, 94070, United States
Rider Research Group
San Francisco, California, 94117, United States
Huntington Medical Foundation
San Marino, California, 91108, United States
Clinical Research of the Rockies
Lafayette, Colorado, 80026, United States
Arapahoe Gastroenterology, PC
Littleton, Colorado, 80120, United States
Litchfield County Gastroenterology Associates, LLC
Torrington, Connecticut, 06790, United States
Madeleine DuPree, MD
Boynton Beach, Florida, 33426, United States
Palmetto Research LLC
Hialeah, Florida, 33016, United States
Mark Lamet, MD
Hollywood, Florida, 33021, United States
Digestive Disease Consultants
Maitland, Florida, 32751, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Miami Research Associates
Miami, Florida, 33143, United States
United Medical Research
New Smyrna Beach, Florida, 32168, United States
West Wind'r Research & Development
Tampa, Florida, 33607, United States
Atlanta Gastroenterology Associates
Marietta, Georgia, 30067, United States
Gastrointestinal Clinical of Quad Cities
Davenport, Iowa, 52807, United States
Sunflower Medical Group
Mission, Kansas, 66202, United States
Kansas Medical Clinic
Topeka, Kansas, 66606, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Maryland Clinical Trials
Annapolis, Maryland, 21401, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Mid Atlantic Medical Research Centers
Hollywood, Maryland, 20636, United States
Charm City Research, LLC
Lutherville, Maryland, 21093, United States
Shah Associates, LLC
Prince Frederick, Maryland, 20678, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202, United States
Center for Digestive & Liver Diseases, Inc
Mexico, Missouri, 65265, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, 08360, United States
NY Center for Clinical Research
Lake Success, New York, 11042, United States
Concorde Medical Group
New York, New York, 10016, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304, United States
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Digestive Health Specialists
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Digestive Specialists Inc.
Dayton, Ohio, 45415, United States
AMH Feasterville Family Health Care Center
Feasterville, Pennsylvania, 19053, United States
Digestive Disorders Center
Pittsburgh, Pennsylvania, 15213, United States
Clinsearch, LLC
Chattanooga, Tennessee, 37404, United States
Memphis Gastroenterology Group, PC
Germantown, Tennessee, 38138, United States
Houston Endoscopy and Research Center
Houston, Texas, 77024, United States
Hidalgo Clinical Research
San Antonio, Texas, 78215, United States
Physician Research Options
Murray, Utah, 84070, United States
Granite Peaks Gastroenterology
Sandy City, Utah, 84094, United States
Northwest Gastroenerology Associates
Bellevue, Washington, 98004, United States
Seattle Gastroenterology Associates
Seattle, Washington, 98133, United States
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
Goiânia, Goiás, 74535-170, Brazil
Universidade Federal de Juiz de Fora
Juiz de Fora, Minas Gerais, 36036-330, Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 21.941-913, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Hospital Sao Lucas PUCRS
Porto Alegre, Rio Grande do Sul, Porto Alegre, Brazil
Fundacao Universidade Federal do Rio Grande - Hopsital Universitario
Rio Grande, Rio Grande do Sul, 96200-310, Brazil
Unidade Integrada de Gastroenterologia UNIGASTRO
Campinas, São Paulo, 13070-040, Brazil
Irmandade da Santa Casa de Misericordia de Santos
Santos, São Paulo, 11075-900, Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, 20551-030, Brazil
Centro de Pesquisas Clinicas- CPCLIN
São Paulo, 01244-030, Brazil
Liver and Intestinal Research Centre
Vancouver, British Columbia, V5Z 1H2, Canada
Topsail Road Medical Clinic
St. John's, Newfoundland and Labrador, A1E 2E2, Canada
Corunna Medical Research Centre
Corunna, Ontario, N0N 1G0, Canada
Cleveland Clinic Canada
Toronto, Ontario, M5J 2T3, Canada
Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1, Canada
Omnispec Clinical Research
Mirabel, Quebec, J7J 2K8, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Gastroenterology Centre
Pointe-Claire, Quebec, H9R 3J1, Canada
Q&T Research
Sherbrooke, Quebec, J1H4J6, Canada
Suomen Terveystalo Oyj
Jyväskylä, 40100, Finland
Kuopio University Hospital
Kuopio, 70211, Finland
Päijat-Häme Central Hospital
Lahti, 15850, Finland
Oulu University Hospital
Oulu, 90220, Finland
Vaasa Central Hospital
Vaasa, 65130, Finland
Synexus ClinPharm GmbH Berlin
Berlin, Berlin (Hellersdorf), 12627, Germany
Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne
Herne, Nord-Rhein-Wesfalen, 44623, Germany
Synexus ClinPharm International GmbH
Bochum, 44787, Germany
Synexus ClinPharm International GmbH
Frankfurt, 60596, Germany
Synexus ClinPharm International GmbH
Görlitz, 02826, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Synexus ClinPharm International GmbH
Leipzig, 04103, Germany
Synexus ClinPharm International GmbH
Magdeburg, 39104, Germany
Synexus ClinPharm International GmbH
Potsdam, 14467, Germany
Peterfy Hospital, Dept. Of Gastroenterology
Budapest, H-1076, Hungary
University of Debrecen, 3rd Dept. Of Medicine
Debrecen, H-4032, Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
Gyula, H-5700, Hungary
Kaposi Mór Teaching Hospital
Kaposvár, H-7400, Hungary
Karolina Hospital, Dept. of Internal Medicine and Gastroenterology
Mosonmagyaróvár, 9200, Hungary
Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat
Vác, 2600, Hungary
Ospedale Valduce
Como, 22100, Italy
Ospedale Fatebenefratelli ed Oftalmico
Milan, 20121, Italy
Universita degli Studi di Padova
Padua, 35128, 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, 27100, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, 00133, Italy
San Camillo Forlanini
Roma, 00151, Italy
Policlinico Univeritario A Gemelli
Roma, 00168, Italy
Policlinico Univeritario A. Gemelli
Roma, 00168, Italy
Meander Medisch Centrum
Amersfoort, 3816, Netherlands
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, 6202, Netherlands
Ikazia Ziekenhuis
Rotterdam, 3083, Netherlands
St. Jans Gashuis
Weert, 6001 BE, Netherlands
CMI de Gastroenterologie Dobru Daniela
Târgu Mureş, Mureș County, 540461, Romania
Spitalul Clinic "Dr. I. Cantacuzino"
Bucharest, 020475, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
Centrul Medical Galenus
Târgu Mureş, 540098, Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara, 300002, Romania
Policlinica "Dr. Citu" SRL
Timișoara, 300593, Romania
Panorama Medi-Clinic
Cape Town, Western Cape, 7500, South Africa
Universitas Hospital
Bloemfontein, 9300, South Africa
Harold Bloch
Cape Town, 7130, South Africa
Panorama Medi-Clinic
Cape Town, 7500, South Africa
Louis Leipoldt Medical Centre
Cape Town, 7530, South Africa
Kingsbury Hospital
Cape Town, 7708, South Africa
Parklands Medical Centre
Durban, 4001, South Africa
Chelmsford Medical Centre 2
Durban, South Africa
Milpark Hospital
Johannesburg, 2006, South Africa
Linksfield Park Clinic
Johannesburg, 2192, South Africa
Johannesburg General Hospital
Johannesburg, 2193, South Africa
Kloof Medi-Clinic
Pretoria, 0143, South Africa
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
December 6, 2007
Primary Completion
November 28, 2011
Study Completion
November 28, 2011
Last Updated
June 11, 2021
Results First Posted
December 19, 2012
Record last verified: 2021-05