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Prevention of Recurrence of Diverticulitis (PREVENT1)

Primary Purpose

Diverticulitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPD476 (1.2g)
SPD476 (2.4 g)
SPD476 (4.8 g)
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

  • Dedicated Clinical Research
  • Lynn Institute of the Ozarks
  • Advanced Clinical Research Institute
  • GW Research
  • Monterey Bay GI Research Institute, Inc
  • Rancho Cucamonga C. Trials
  • Clinical Trials Research
  • Medical Associates Research
  • Torrance Clinical Research
  • Rocky Mountain Gastroenterology Associates
  • Gastroenterology Associates of Fairfield County
  • Yale Center for Clinical Investigation
  • ZASA Clinical Research
  • Clinical Research of West Florida, Inc.
  • Borland-Groover Clinic
  • Compass Research
  • Accord Clinic Research, LLC
  • Florida Medical Clinic/Tampa Clinical Trials
  • Gastroenterology Associates of Central Georgia, LLC
  • Saint John's Research Institute
  • Digestive & Liver Disease Consultants
  • New Orleans Research Institute
  • Digestive Disease Associates
  • Endoscopic Microsurgery Associates, PA
  • Borgess Research Institute
  • Jefferson City Medical Group
  • South Jersey Gastroenterology, P.A.
  • Howard Guss, DO
  • New Jersey Physicians, LLC
  • Allied Gastrointestinal Associates, P.A.
  • Regional Clinical Research
  • Long Island Clinical Research Associates
  • Long Island Gastrointestinal Research Group
  • Research Associates of New York
  • Vital Research
  • Gastroenterology Specialists, Inc
  • Memorial Research Center
  • Gastroenterology Associates Clinical Research
  • Nashville Medical Research Institute
  • Harris Methodist Fort Worth Hospital
  • Kelsey-Seybold Clinic
  • Clinical Trials of Texas, Inc.
  • Stone Oak Research Foundation
  • Blue Ridge Medical Research
  • Digestive and Liver Disease Specialists
  • Aurora Advanced Healthcare, Inc. - Clinical Research Center
  • CIMEL
  • Instituto Gamma
  • Hospital Bocalandro
  • Hospital Heroes de Malvinas
  • GEDYT
  • Sanatorio Guemes
  • Cibic S.A.
  • The Canberra Hospital
  • Ballarat Base Hospital
  • St Vincent's Hospital (Melb) LTD
  • Royal Adelaide Hospital
  • Royal Prince Albert Hospital
  • Frankston Private
  • Bayside Gastroenterology
  • Fremantle Hospital
  • Ugasend S.A
  • Clinica Colsinatas SA
  • FOQUS, Centro de Investigacion Clinica
  • Fundacion Clinica Abood Shaio
  • Hospital Universitario San Ignacio
  • Clinica Las Americas
  • CHU de Strasbourg
  • Hepato Gastro Enterology
  • Hopital Charles Nicolle
  • Hopital Beaujon
  • Cabinet de Gastro-enterologie du Dr Alain Thevenin
  • Hopital I'Archet
  • Clinique Bouchard
  • CHU de Grenoble
  • Cabinet du Dr Olivier Delette
  • Dr Michel Regensberg
  • Baby Memorial Hospital
  • Lakeshore Hospital & Research Centre Ltd
  • Sree Gokulam Medical College and Research Foundation
  • Dayanand Medical College and Hospital
  • S R Kalla Memorial Hospital
  • Aceer
  • Institute of Postgraduate Medical Education and Research
  • Brahmin Mitra Mandal Society
  • Ruby Hall Clinic
  • Krishna Institute of Medical Sciences
  • Emek Medical Center
  • Barzilai Medical Centre
  • Soroka Medical Center
  • Bnai Zion Medical Center
  • Rambam Medical Center
  • Hadassah Ein-Karem Medical Center
  • Meir Medical Centre
  • Rabin Medical Center
  • Kaplan Medical Center
  • The Tel Aviv Sourasky Medical Center
  • The Chaim Sheba Medical Center
  • Assaf Harofeh Medical Center
  • Shakespeare Specialist Group
  • Auckland City Hospital
  • CURT Medical Trials Trust Board
  • Dunedin Hospital
  • Waikato Hospital
  • Tauranga Hospital
  • Hospital Valle de Hebron
  • Hospital Universitario de Bellvitge
  • Hospital Son Dureta
  • Hospital de Donostia
  • Hospital General Universitario de Valencia
  • University Hospital/Eastern Hospital
  • University Hospital Linköping
  • VO Internmedicin
  • Karolinska University Hospital
  • Danderyd Hospital
  • Kirurgkliniken
  • Norfolk/Norwich University Hospital
  • St Mark's Hospital
  • King's College Hospital
  • Chelsea & Westminster Hospital
  • Imperial College London

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 Were 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 8, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00545740
Brief Title
Prevention of Recurrence of Diverticulitis
Acronym
PREVENT1
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
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2007 (Actual)
Primary Completion Date
March 5, 2012 (Actual)
Study Completion Date
March 5, 2012 (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
590 (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 (1.2g)
Other Intervention Name(s)
Lialda, MMX™ mesalazine
Intervention Description
1.2g SPD476 once daily (QD) orally
Intervention Type
Drug
Intervention Name(s)
SPD476 (2.4 g)
Other Intervention Name(s)
Lialda, MMX™ mesalazine
Intervention Description
2.4g SPD476 QD orally
Intervention Type
Drug
Intervention Name(s)
SPD476 (4.8 g)
Other Intervention Name(s)
Lialda, MMX™ mesalazine
Intervention Description
4.8g SPD476 QD orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
QD orally
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 Were 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
Dedicated Clinical Research
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
GW Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Monterey Bay GI Research Institute, Inc
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Rancho Cucamonga C. Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Clinical Trials Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Medical Associates Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Yale Center for Clinical Investigation
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
ZASA Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Accord Clinic Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Florida Medical Clinic/Tampa Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Saint John's Research Institute
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Digestive & Liver Disease Consultants
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
New Orleans Research Institute
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Digestive Disease Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Endoscopic Microsurgery Associates, PA
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Jefferson City Medical Group
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
South Jersey Gastroenterology, P.A.
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Howard Guss, DO
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
New Jersey Physicians, LLC
City
Passaic
State/Province
New Jersey
ZIP/Postal Code
07055
Country
United States
Facility Name
Allied Gastrointestinal Associates, P.A.
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Regional Clinical Research
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Research Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Vital Research
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Gastroenterology Specialists, Inc
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Memorial Research Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Gastroenterology Associates Clinical Research
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Harris Methodist Fort Worth Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Kelsey-Seybold Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Stone Oak Research Foundation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Aurora Advanced Healthcare, Inc. - Clinical Research Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
CIMEL
City
Lanus
State/Province
Buenos Aires
ZIP/Postal Code
B1824KAS
Country
Argentina
Facility Name
Instituto Gamma
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DFD
Country
Argentina
Facility Name
Hospital Bocalandro
City
Buenos Aires
ZIP/Postal Code
B1657BHD
Country
Argentina
Facility Name
Hospital Heroes de Malvinas
City
Buenos Aires
ZIP/Postal Code
B1722FJN
Country
Argentina
Facility Name
GEDYT
City
Buenos Aires
ZIP/Postal Code
C1117AAA
Country
Argentina
Facility Name
Sanatorio Guemes
City
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Cibic S.A.
City
Santa Fe
ZIP/Postal Code
S2000BCG
Country
Argentina
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Ballarat Base Hospital
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
St Vincent's Hospital (Melb) LTD
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Prince Albert Hospital
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Frankston Private
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Facility Name
Bayside Gastroenterology
City
Frankston
ZIP/Postal Code
VIC 3199
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
Ugasend S.A
City
Barranquilla
Country
Colombia
Facility Name
Clinica Colsinatas SA
City
Bogota
Country
Colombia
Facility Name
FOQUS, Centro de Investigacion Clinica
City
Bogota
Country
Colombia
Facility Name
Fundacion Clinica Abood Shaio
City
Bogota
Country
Colombia
Facility Name
Hospital Universitario San Ignacio
City
Bogota
Country
Colombia
Facility Name
Clinica Las Americas
City
Medellin
Country
Colombia
Facility Name
CHU de Strasbourg
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67200
Country
France
Facility Name
Hepato Gastro Enterology
City
Nantes
State/Province
Brittany
ZIP/Postal Code
44033
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
State/Province
Normandy
ZIP/Postal Code
76031
Country
France
Facility Name
Hopital Beaujon
City
Clichy
State/Province
Paris
ZIP/Postal Code
92118
Country
France
Facility Name
Cabinet de Gastro-enterologie du Dr Alain Thevenin
City
Saint Quentin
State/Province
Picardie
ZIP/Postal Code
02100
Country
France
Facility Name
Hopital I'Archet
City
Nice
State/Province
Provence-Alpes-Côte d'Azur
ZIP/Postal Code
06200
Country
France
Facility Name
Clinique Bouchard
City
Marseille
State/Province
Provence-Alpes-Côte-d'Azur
ZIP/Postal Code
13000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
State/Province
Rhone-Alpes
ZIP/Postal Code
38043
Country
France
Facility Name
Cabinet du Dr Olivier Delette
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Dr Michel Regensberg
City
Paris
ZIP/Postal Code
75017
Country
France
Facility Name
Baby Memorial Hospital
City
Calicut
State/Province
Kerala
ZIP/Postal Code
673004
Country
India
Facility Name
Lakeshore Hospital & Research Centre Ltd
City
Cochin
State/Province
Kerala
ZIP/Postal Code
682304
Country
India
Facility Name
Sree Gokulam Medical College and Research Foundation
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695607
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
S R Kalla Memorial Hospital
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Aceer
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600020
Country
India
Facility Name
Institute of Postgraduate Medical Education and Research
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Brahmin Mitra Mandal Society
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
ZIP/Postal Code
411 001
Country
India
Facility Name
Krishna Institute of Medical Sciences
City
Secunderabad
ZIP/Postal Code
500 003
Country
India
Facility Name
Emek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Barzilai Medical Centre
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
63106
Country
Israel
Facility Name
Hadassah Ein-Karem Medical Center
City
Jerusalem
Country
Israel
Facility Name
Meir Medical Centre
City
Kfar-Saba
Country
Israel
Facility Name
Rabin Medical Center
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
Country
Israel
Facility Name
The Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Shakespeare Specialist Group
City
Takapuna
State/Province
Auckland
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
CURT Medical Trials Trust Board
City
Christchurch
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
Country
New Zealand
Facility Name
Hospital Valle de Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital de Donostia
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
University Hospital/Eastern Hospital
City
Goteborg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
University Hospital Linköping
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
VO Internmedicin
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Kirurgkliniken
City
Uppsala
Country
Sweden
Facility Name
Norfolk/Norwich University Hospital
City
Norwich
State/Province
East Anglia
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
St Mark's Hospital
City
Harrow
State/Province
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Chelsea & Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

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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