Prevention of Recurrence of Diverticulitis (PREVENT2)

June 1, 2021 updated by: Shire

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

592

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo administered Once Daily (QD)
EXPERIMENTAL: SPD476 (1.2 g)
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 1.2g administered Once Daily (QD)
Other Names:
  • LIALDA
EXPERIMENTAL: SPD476 (2.4 g)
Drug: SPD476, MMX™ mesalazine, 2.4g extended release tablet
SPD476 2.4g administered Once Daily (QD)
Other Names:
  • LIALDA
EXPERIMENTAL: SPD476 (4.8 g)
Drug: SPD476, MMX™ mesalazine, 4.8g extended release tablet
SPD476 4.8g administered Once Daily (QD)
Other Names:
  • LIALDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects Without Recurrence of Diverticulitis
Time Frame: up to 104 Weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis
Time Frame: up to 104 weeks
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
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Time Frame: up to 104 Weeks
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
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Time Frame: up to 104 weeks
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
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Time Frame: up to 104 weeks
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
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Time Frame: up to 104 weeks
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
Percent of Subjects Requiring Surgery for Diverticulitis
Time Frame: up to 104 Weeks
up to 104 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 6, 2007

Primary Completion (ACTUAL)

November 28, 2011

Study Completion (ACTUAL)

November 28, 2011

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (ESTIMATE)

October 17, 2007

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD476-314
  • 2007-004896-20 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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