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Prevention of Recurrence of Diverticulitis (PREVENT2)

Primary Purpose

Diverticulitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476, MMX™ mesalazine, 2.4g extended release tablet
SPD476, MMX™ mesalazine, 4.8g extended release tablet
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diverticulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Gastroenterology Associates, PC
  • Alabama Clinical Therapeutics, LLC
  • Medical Affiliated Research Center, Inc
  • Alabama Digestive Disorders Center, PC
  • Genova Clinical Research
  • Digestive and Liver Disease Specialists
  • High Desert Gastroenterology, Inc.
  • VA Long Beach Healthcare System
  • CA Physicians Research Alliance
  • Digestive Care Medical Center
  • Rider Research Group
  • Huntington Medical Foundation
  • Clinical Research of the Rockies
  • Arapahoe Gastroenterology, PC
  • Litchfield County Gastroenterology Associates, LLC
  • Madeleine DuPree, MD
  • Palmetto Research LLC
  • Mark Lamet, MD
  • Digestive Disease Consultants
  • University of Miami Miller School of Medicine
  • University of Miami
  • Miami Research Associates
  • United Medical Research
  • West Wind'r Research & Development
  • Atlanta Gastroenterology Associates
  • Gastrointestinal Clinical of Quad Cities
  • Sunflower Medical Group
  • Kansas Medical Clinic
  • Gastroenterology Associates, LLC
  • Louisiana Research Center, LLC
  • Maryland Clinical Trials
  • Chevy Chase Clinical Research
  • Mid Atlantic Medical Research Centers
  • Charm City Research, LLC
  • Shah Associates, LLC
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health
  • Gastrointestinal Associates, PA
  • Center for Digestive & Liver Diseases, Inc
  • Sundance Clinical Research
  • The Gastroenterology Group of South Jersey
  • NY Center for Clinical Research
  • Concorde Medical Group
  • Cumberland Research Associates
  • LeBauer Research Associates, PA
  • Wake Research Associates
  • Digestive Health Specialists
  • Consultants for Clinical Research
  • Digestive Specialists Inc.
  • AMH Feasterville Family Health Care Center
  • Digestive Disorders Center
  • Clinsearch, LLC
  • Memphis Gastroenterology Group, PC
  • Houston Endoscopy and Research Center
  • Hidalgo Clinical Research
  • Physician Research Options
  • Granite Peaks Gastroenterology
  • Northwest Gastroenerology Associates
  • Seattle Gastroenterology Associates
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
  • Universidade Federal de Juiz de Fora
  • Hospital Universitário Clementino Fraga Filho
  • Hospital de Clinicas de Porto Alegre
  • Hospital Sao Lucas PUCRS
  • Fundacao Universidade Federal do Rio Grande - Hopsital Universitario
  • Irmandade da Santa Casa de Misericordia de Santos
  • Unidade Integrada de Gastroenterologia UNIGASTRO
  • Hospital Universitario Pedro Ernesto
  • Centro de Pesquisas Clinicas- CPCLIN
  • Liver and Intestinal Research Centre
  • Topsail Road Medical Clinic
  • Corunna Medical Research Centre
  • Cleveland Clinic Canada
  • Hotel-Dieu de Levis
  • Omnispec Clinical Research
  • Hopital Maisonneuve-Rosemont
  • Gastroenterology Centre
  • Q&T Research
  • Suomen Terveystalo Oyj
  • Kuopio University Hospital
  • Päijat-Häme Central Hospital
  • Oulu University Hospital
  • Vaasa Central Hospital
  • Synexus ClinPharm GmbH Berlin
  • Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne
  • Synexus ClinPharm International GmbH
  • Synexus ClinPharm International GmbH
  • Synexus ClinPharm International GmbH
  • Universitätsklinikum Schleswig-Holstein
  • Synexus ClinPharm International GmbH
  • Synexus ClinPharm International GmbH
  • Synexus ClinPharm International GmbH
  • Peterfy Hospital, Dept. Of Gastroenterology
  • University of Debrecen, 3rd Dept. Of Medicine
  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
  • Kaposi Mór Teaching Hospital
  • Karolina Hospital, Dept. of Internal Medicine and Gastroenterology
  • Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat
  • Ospedale Valduce
  • Ospedale Fatebenefratelli ed Oftalmico
  • Universita degli Studi di Padova
  • U.O. di Gastroenterologia ed Endoscopia digestiva Torre delle Medicine Azienda Ospedaliera di Parma
  • Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • San Camillo Forlanini
  • Policlinico Univeritario A Gemelli
  • Policlinico Univeritario A. Gemelli
  • Meander Medisch Centrum
  • VU Medisch Centrum
  • Academisch Ziekenhuis Maastricht
  • Ikazia Ziekenhuis
  • St. Jans Gashuis
  • CMI de Gastroenterologie Dobru Daniela
  • Spitalul Clinic "Dr. I. Cantacuzino"
  • Institutul Clinic Fundeni
  • Spitalul Universitar de Urgenta Bucuresti
  • Centrul Medical Galenus
  • Cabinet Particular Policlinic Algomed SRL
  • Policlinica "Dr. Citu" SRL
  • Panorama Medi-Clinic
  • Universitas Hospital
  • Harold Bloch
  • Panorama Medi-Clinic
  • Louis Leipoldt Medical Centre
  • Kingsbury Hospital
  • Parklands Medical Centre
  • Chelmsford Medical Centre 2
  • Milpark Hospital
  • Linksfield Park Clinic
  • Johannesburg General Hospital
  • Kloof Medi-Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SPD476 (1.2 g)

SPD476 (2.4 g)

SPD476 (4.8 g)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis
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.
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
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.
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
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.
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
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.
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
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.
Percent of Subjects Requiring Surgery for Diverticulitis

Full Information

First Posted
October 16, 2007
Last Updated
June 1, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00545103
Brief Title
Prevention of Recurrence of Diverticulitis
Acronym
PREVENT2
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2007 (Actual)
Primary Completion Date
November 28, 2011 (Actual)
Study Completion Date
November 28, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
592 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPD476 (1.2 g)
Arm Type
Experimental
Arm Title
SPD476 (2.4 g)
Arm Type
Experimental
Arm Title
SPD476 (4.8 g)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD476, MMX™ mesalazine, 1.2g extended release tablet
Other Intervention Name(s)
LIALDA
Intervention Description
SPD476 1.2g administered Once Daily (QD)
Intervention Type
Drug
Intervention Name(s)
SPD476, MMX™ mesalazine, 2.4g extended release tablet
Other Intervention Name(s)
LIALDA
Intervention Description
SPD476 2.4g administered Once Daily (QD)
Intervention Type
Drug
Intervention Name(s)
SPD476, MMX™ mesalazine, 4.8g extended release tablet
Other Intervention Name(s)
LIALDA
Intervention Description
SPD476 4.8g administered Once Daily (QD)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered Once Daily (QD)
Primary Outcome Measure Information:
Title
Percent of Subjects Without Recurrence of Diverticulitis
Description
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.
Time Frame
up to 104 Weeks
Secondary Outcome Measure Information:
Title
Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis
Description
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.
Time Frame
up to 104 weeks
Title
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Description
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.
Time Frame
up to 104 Weeks
Title
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Description
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.
Time Frame
up to 104 weeks
Title
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Description
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.
Time Frame
up to 104 weeks
Title
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Description
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.
Time Frame
up to 104 weeks
Title
Percent of Subjects Requiring Surgery for Diverticulitis
Time Frame
up to 104 Weeks

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
25038431
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.
Results Reference
derived

Learn more about this trial

Prevention of Recurrence of Diverticulitis

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