Prevention of Recurrence of Diverticulitis

PHASE3CompletedINTERVENTIONAL
Enrollment

592

Participants

Timeline

Start Date

December 6, 2007

Primary Completion Date

November 28, 2011

Study Completion Date

November 28, 2011

Conditions
Diverticulitis
Interventions
DRUG

SPD476, MMX™ mesalazine, 1.2g extended release tablet

SPD476 1.2g administered Once Daily (QD)

DRUG

SPD476, MMX™ mesalazine, 2.4g extended release tablet

SPD476 2.4g administered Once Daily (QD)

DRUG

SPD476, MMX™ mesalazine, 4.8g extended release tablet

SPD476 4.8g administered Once Daily (QD)

DRUG

Placebo

Placebo administered Once Daily (QD)

Trial Locations (131)

2006

Milpark Hospital, Johannesburg

2192

Linksfield Park Clinic, Johannesburg

2193

Johannesburg General Hospital, Johannesburg

2600

Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat, Vác

3083

Ikazia Ziekenhuis, Rotterdam

3816

Meander Medisch Centrum, Amersfoort

4001

Parklands Medical Centre, Durban

6202

Academisch Ziekenhuis Maastricht, Maastricht

7130

Harold Bloch, Cape Town

7500

Panorama Medi-Clinic, Cape Town

Panorama Medi-Clinic, Cape Town

7530

Louis Leipoldt Medical Centre, Cape Town

7708

Kingsbury Hospital, Cape Town

9200

Karolina Hospital, Dept. of Internal Medicine and Gastroenterology, Mosonmagyaróvár

9300

Universitas Hospital, Bloemfontein

10016

Concorde Medical Group, New York

11042

NY Center for Clinical Research, Lake Success

12627

Synexus ClinPharm GmbH Berlin, Berlin

14467

Synexus ClinPharm International GmbH, Potsdam

15213

Digestive Disorders Center, Pittsburgh

15850

Päijat-Häme Central Hospital, Lahti

19053

AMH Feasterville Family Health Care Center, Feasterville

20121

Ospedale Fatebenefratelli ed Oftalmico, Milan

20636

Mid Atlantic Medical Research Centers, Hollywood

20678

Shah Associates, LLC, Prince Frederick

20815

Chevy Chase Clinical Research, Chevy Chase

21093

Charm City Research, LLC, Lutherville

21401

Maryland Clinical Trials, Annapolis

22100

Ospedale Valduce, Como

24105

Universitätsklinikum Schleswig-Holstein, Kiel

27100

Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina, Pavia

27103

Digestive Health Specialists, Winston-Salem

27403

LeBauer Research Associates, PA, Greensboro

27612

Wake Research Associates, Raleigh

28304

Cumberland Research Associates, Fayetteville

30067

Atlanta Gastroenterology Associates, Marietta

32168

United Medical Research, New Smyrna Beach

32751

Digestive Disease Consultants, Maitland

33016

Palmetto Research LLC, Hialeah

33021

Mark Lamet, MD, Hollywood

33136

University of Miami Miller School of Medicine, Miami

University of Miami, Miami

33143

Miami Research Associates, Miami

33426

Madeleine DuPree, MD, Boynton Beach

33607

West Wind'r Research & Development, Tampa

35128

Universita degli Studi di Padova, Padua

35209

Birmingham Gastroenterology Associates, PC, Birmingham

35235

Alabama Clinical Therapeutics, LLC, Birmingham

35801

Medical Affiliated Research Center, Inc, Huntsville

35802

Alabama Digestive Disorders Center, PC, Huntsville

37404

Clinsearch, LLC, Chattanooga

38138

Memphis Gastroenterology Group, PC, Germantown

39104

Synexus ClinPharm International GmbH, Magdeburg

39202

Gastrointestinal Associates, PA, Jackson

40100

Suomen Terveystalo Oyj, Jyväskylä

44623

Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne, Herne

44787

Synexus ClinPharm International GmbH, Bochum

45219

Consultants for Clinical Research, Cincinnati

45415

Digestive Specialists Inc., Dayton

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48098

Center for Digestive Health, Troy

52807

Gastrointestinal Clinical of Quad Cities, Davenport

60596

Synexus ClinPharm International GmbH, Frankfurt

63141

Sundance Clinical Research, St Louis

65130

Vaasa Central Hospital, Vaasa

65265

Center for Digestive & Liver Diseases, Inc, Mexico

66202

Sunflower Medical Group, Mission

66606

Kansas Medical Clinic, Topeka

70211

Kuopio University Hospital, Kuopio

70809

Gastroenterology Associates, LLC, Baton Rouge

71103

Louisiana Research Center, LLC, Shreveport

77024

Houston Endoscopy and Research Center, Houston

78215

Hidalgo Clinical Research, San Antonio

80026

Clinical Research of the Rockies, Lafayette

80120

Arapahoe Gastroenterology, PC, Littleton

84070

Physician Research Options, Murray

84094

Granite Peaks Gastroenterology, Sandy City

85741

Genova Clinical Research, Tucson

90220

Oulu University Hospital, Oulu

90822

VA Long Beach Healthcare System, Long Beach

91108

Huntington Medical Foundation, San Marino

92083

CA Physicians Research Alliance, Oceanside

92840

Digestive and Liver Disease Specialists, Garden Grove

93534

High Desert Gastroenterology, Inc., Lancaster

94070

Digestive Care Medical Center, San Carlos

94117

Rider Research Group, San Francisco

98004

Northwest Gastroenerology Associates, Bellevue

98133

Seattle Gastroenterology Associates, Seattle

300002

Cabinet Particular Policlinic Algomed SRL, Timișoara

300593

"Policlinica Dr. Citu SRL", Timișoara

540098

Centrul Medical Galenus, Târgu Mureş

540461

CMI de Gastroenterologie Dobru Daniela, Târgu Mureş

06790

Litchfield County Gastroenterology Associates, LLC, Torrington

08360

The Gastroenterology Group of South Jersey, Vineland

74535-170

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda., Goiânia

36036-330

Universidade Federal de Juiz de Fora, Juiz de Fora

21.941-913

Hospital Universitário Clementino Fraga Filho, Rio de Janeiro

90035-003

Hospital de Clinicas de Porto Alegre, Porto Alegre

Porto Alegre

Hospital Sao Lucas PUCRS, Porto Alegre

96200-310

Fundacao Universidade Federal do Rio Grande - Hopsital Universitario, Rio Grande

13070-040

Unidade Integrada de Gastroenterologia UNIGASTRO, Campinas

11075-900

Irmandade da Santa Casa de Misericordia de Santos, Santos

20551-030

Hospital Universitario Pedro Ernesto, Rio de Janeiro

01244-030

Centro de Pesquisas Clinicas- CPCLIN, São Paulo

V5Z 1H2

Liver and Intestinal Research Centre, Vancouver

A1E 2E2

Topsail Road Medical Clinic, St. John's

N0N 1G0

Corunna Medical Research Centre, Corunna

M5J 2T3

Cleveland Clinic Canada, Toronto

G6V 3Z1

Hotel-Dieu de Levis, Lévis

J7J 2K8

Omnispec Clinical Research, Mirabel

H1T 2M4

Hopital Maisonneuve-Rosemont, Montreal

H9R 3J1

Gastroenterology Centre, Pointe-Claire

J1H4J6

Q&T Research, Sherbrooke

02826

Synexus ClinPharm International GmbH, Görlitz

04103

Synexus ClinPharm International GmbH, Leipzig

H-1076

Peterfy Hospital, Dept. Of Gastroenterology, Budapest

H-4032

University of Debrecen, 3rd Dept. Of Medicine, Debrecen

H-5700

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium, Gyula

H-7400

Kaposi Mór Teaching Hospital, Kaposvár

Unknown

U.O. di Gastroenterologia ed Endoscopia digestiva Torre delle Medicine Azienda Ospedaliera di Parma, Parma

Chelmsford Medical Centre 2, Durban

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma

00151

San Camillo Forlanini, Roma

00168

Policlinico Univeritario A Gemelli, Roma

Policlinico Univeritario A. Gemelli, Roma

1081 HV

VU Medisch Centrum, Amsterdam

6001 BE

St. Jans Gashuis, Weert

020475

"Spitalul Clinic Dr. I. Cantacuzino", Bucharest

022328

Institutul Clinic Fundeni, Bucharest

050098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

0143

Kloof Medi-Clinic, Pretoria

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY