Prevention of Recurrence of Diverticulitis

Last updated: June 1, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Intra-abdominal Infections

Treatment

N/A

Clinical Study ID

NCT00545103
SPD476-314
2007-004896-20
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 anyapplicable 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 atleast three diverticula noted

Exclusion

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 wellas 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 nasalsteroids is acceptable
  11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (exceptfor 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 toBaseline
  14. Females who are lactating

Study Design

Total Participants: 592
Study Start date:
December 06, 2007
Estimated Completion Date:
November 28, 2011

Connect with a study center

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.

    Goiania, GO 74535-170
    Brazil

    Site Not Available

  • Universidade Federal de Juiz de Fora

    Juiz de Fora, MG 36036-330
    Brazil

    Site Not Available

  • Hospital Universitário Clementino Fraga Filho

    Rio de Janeiro, RJ 21.941-913
    Brazil

    Site Not Available

  • Hospital Sao Lucas PUCRS

    Porto Alegre, RS Porto Alegre
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, RS 90035-003
    Brazil

    Site Not Available

  • Fundacao Universidade Federal do Rio Grande - Hopsital Universitario

    Rio Grande, RS 96200-310
    Brazil

    Site Not Available

  • Unidade Integrada de Gastroenterologia UNIGASTRO

    Campinas, SP 13070-040
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Santos

    Santos, Sao Paolo 11075-900
    Brazil

    Site Not Available

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro, 20551-030
    Brazil

    Site Not Available

  • Centro de Pesquisas Clinicas- CPCLIN

    Sao Paulo, 01244-030
    Brazil

    Site Not Available

  • Liver and Intestinal Research Centre

    Vancouver, British Columbia V5Z 1H2
    Canada

    Site Not Available

  • Topsail Road Medical Clinic

    St John's, Newfoundland and Labrador A1E 2E2
    Canada

    Site Not Available

  • Corunna Medical Research Centre

    Corunna, Ontario N0N 1G0
    Canada

    Site Not Available

  • Cleveland Clinic Canada

    Toronto, Ontario M5J 2T3
    Canada

    Site Not Available

  • Hotel-Dieu de Levis

    Levis, Quebec G6V 3Z1
    Canada

    Site Not Available

  • Omnispec Clinical Research

    Mirabel, Quebec J7J 2K8
    Canada

    Site Not Available

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Gastroenterology Centre

    Pointe-Claire, Quebec H9R 3J1
    Canada

    Site Not Available

  • Q&T Research

    Sherbrooke, Quebec J1H4J6
    Canada

    Site Not Available

  • Suomen Terveystalo Oyj

    Jyvaskyla, 40100
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio, 70211
    Finland

    Site Not Available

  • Päijat-Häme Central Hospital

    Lahti, 15850
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu, 90220
    Finland

    Site Not Available

  • Vaasa Central Hospital

    Vaasa, 65130
    Finland

    Site Not Available

  • Synexus ClinPharm GmbH Berlin

    Berlin, Berlin (Hellersdorf) 12627
    Germany

    Site Not Available

  • Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne

    Herne, Nord-Rhein-Wesfalen 44623
    Germany

    Site Not Available

  • Synexus ClinPharm International GmbH

    Bochum, 44787
    Germany

    Site Not Available

  • Synexus ClinPharm International GmbH

    Frankfurt, 60596
    Germany

    Site Not Available

  • Synexus ClinPharm International GmbH

    Görlitz, 02826
    Germany

    Site Not Available

  • Synexus ClinPharm International GmbH

    Görlitz, 02826
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • Synexus ClinPharm International GmbH

    Leipzig, 04103
    Germany

    Site Not Available

  • Synexus ClinPharm International GmbH

    Magdeburg, 39104
    Germany

    Site Not Available

  • Synexus ClinPharm International GmbH

    Potsdam, 14467
    Germany

    Site Not Available

  • Peterfy Hospital, Dept. Of Gastroenterology

    Budapest, H-1076
    Hungary

    Site Not Available

  • University of Debrecen, 3rd Dept. Of Medicine

    Debrecen, H-4032
    Hungary

    Site Not Available

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium

    Gyula, H-5700
    Hungary

    Site Not Available

  • Kaposi Mór Teaching Hospital

    Kaposvár, H-7400
    Hungary

    Site Not Available

  • Kaposi Mór Teaching Hospital

    Kaposvár, H-7400
    Hungary

    Site Not Available

  • Karolina Hospital, Dept. of Internal Medicine and Gastroenterology

    Mosonmagyaróvár, 9200
    Hungary

    Site Not Available

  • Karolina Hospital, Dept. of Internal Medicine and Gastroenterology

    Mosonmagyaróvár, 9200
    Hungary

    Site Not Available

  • Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat

    Vác, 2600
    Hungary

    Site Not Available

  • Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat

    Vác, 2600
    Hungary

    Site Not Available

  • Ospedale Valduce

    Como, 22100
    Italy

    Site Not Available

  • Ospedale Fatebenefratelli ed Oftalmico

    Milano, 20121
    Italy

    Site Not Available

  • Universita degli Studi di Padova

    Padova, 35128
    Italy

    Site Not Available

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

    Parma,
    Italy

    Site Not Available

  • Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • Policlinico Univeritario A Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Policlinico Univeritario A. Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • San Camillo Forlanini

    Roma, 00151
    Italy

    Site Not Available

  • Meander Medisch Centrum

    Amersfoort, 3816
    Netherlands

    Site Not Available

  • VU Medisch Centrum

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202
    Netherlands

    Site Not Available

  • Ikazia Ziekenhuis

    Rotterdam, 3083
    Netherlands

    Site Not Available

  • St. Jans Gashuis

    Weert, 6001 BE
    Netherlands

    Site Not Available

  • CMI de Gastroenterologie Dobru Daniela

    Targu Mures, Mures 540461
    Romania

    Site Not Available

  • Institutul Clinic Fundeni

    Bucharest, 022328
    Romania

    Site Not Available

  • Spitalul Clinic "Dr. I. Cantacuzino"

    Bucharest, 020475
    Romania

    Site Not Available

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098
    Romania

    Site Not Available

  • Centrul Medical Galenus

    Targu Mures, 540098
    Romania

    Site Not Available

  • Cabinet Particular Policlinic Algomed SRL

    Timisoara, 300002
    Romania

    Site Not Available

  • Policlinica "Dr. Citu" SRL

    Timisoara, 300593
    Romania

    Site Not Available

  • Centrul Medical Galenus

    Tirgu Mures, 540098
    Romania

    Site Not Available

  • Universitas Hospital

    Bloemfontein, 9300
    South Africa

    Site Not Available

  • Harold Bloch

    Cape Town, 7130
    South Africa

    Site Not Available

  • Kingsbury Hospital

    Cape Town, 7708
    South Africa

    Site Not Available

  • Louis Leipoldt Medical Centre

    Cape Town, 7530
    South Africa

    Site Not Available

  • Panorama Medi-Clinic

    Cape Town, 7500
    South Africa

    Site Not Available

  • Chelmsford Medical Centre 2

    Durban,
    South Africa

    Site Not Available

  • Parklands Medical Centre

    Durban, 4001
    South Africa

    Site Not Available

  • Johannesburg General Hospital

    Johannesburg, 2193
    South Africa

    Site Not Available

  • Linksfield Park Clinic

    Johannesburg, 2192
    South Africa

    Site Not Available

  • Milpark Hospital

    Johannesburg, 2006
    South Africa

    Site Not Available

  • Kloof Medi-Clinic

    Pretoria, 0143
    South Africa

    Site Not Available

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • Birmingham Gastroenterology Associates, PC

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Alabama Digestive Disorders Center, PC

    Huntsville, Alabama 35802
    United States

    Site Not Available

  • Medical Affiliated Research Center, Inc

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Genova Clinical Research

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Digestive and Liver Disease Specialists

    Garden Grove, California 92840
    United States

    Site Not Available

  • High Desert Gastroenterology, Inc.

    Lancaster, California 93534
    United States

    Site Not Available

  • VA Long Beach Healthcare System

    Long Beach, California 90822
    United States

    Site Not Available

  • CA Physicians Research Alliance

    Oceanside, California 92083
    United States

    Site Not Available

  • Digestive Care Medical Center

    San Carlos, California 94070
    United States

    Site Not Available

  • Rider Research Group

    San Francisco, California 94117
    United States

    Site Not Available

  • Huntington Medical Foundation

    San Marino, California 91108
    United States

    Site Not Available

  • Clinical Research of the Rockies

    Lafayette, Colorado 80026
    United States

    Site Not Available

  • Arapahoe Gastroenterology, PC

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Litchfield County Gastroenterology Associates, LLC

    Torrington, Connecticut 06790
    United States

    Site Not Available

  • Madeleine DuPree, MD

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Palmetto Research LLC

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Mark Lamet, MD

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Digestive Disease Consultants

    Maitland, Florida 32751
    United States

    Site Not Available

  • Miami Research Associates

    Miami, Florida 33143
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • United Medical Research

    New Smyrna Beach, Florida 32168
    United States

    Site Not Available

  • West Wind'r Research & Development

    Tampa, Florida 33607
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates

    Marietta, Georgia 30067
    United States

    Site Not Available

  • Gastrointestinal Clinical of Quad Cities

    Davenport, Iowa 52807
    United States

    Site Not Available

  • Sunflower Medical Group

    Mission, Kansas 66202
    United States

    Site Not Available

  • Kansas Medical Clinic

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Maryland Clinical Trials

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Mid Atlantic Medical Research Centers

    Hollywood, Maryland 20636
    United States

    Site Not Available

  • Charm City Research, LLC

    Lutherville, Maryland 21093
    United States

    Site Not Available

  • Shah Associates, LLC

    Prince Frederick, Maryland 20678
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Center for Digestive Health

    Troy, Michigan 48098
    United States

    Site Not Available

  • Gastrointestinal Associates, PA

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Center for Digestive & Liver Diseases, Inc

    Mexico, Missouri 65265
    United States

    Site Not Available

  • Sundance Clinical Research

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Sundance Clinical Research

    St Louis, Missouri 63141
    United States

    Site Not Available

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey 08360
    United States

    Site Not Available

  • NY Center for Clinical Research

    Lake Success, New York 11042
    United States

    Site Not Available

  • Concorde Medical Group

    New York, New York 10016
    United States

    Site Not Available

  • Cumberland Research Associates

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • LeBauer Research Associates, PA

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Wake Research Associates

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Digestive Health Specialists

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Consultants for Clinical Research

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Digestive Specialists Inc.

    Dayton, Ohio 45415
    United States

    Site Not Available

  • AMH Feasterville Family Health Care Center

    Feasterville, Pennsylvania 19053
    United States

    Site Not Available

  • Digestive Disorders Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Clinsearch, LLC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Memphis Gastroenterology Group, PC

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Houston Endoscopy and Research Center

    Houston, Texas 77024
    United States

    Site Not Available

  • Hidalgo Clinical Research

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Physician Research Options

    Murray, Utah 84070
    United States

    Site Not Available

  • Physician Research Options

    Murry, Utah 84070
    United States

    Site Not Available

  • Granite Peaks Gastroenterology

    Sandy, Utah 84094
    United States

    Site Not Available

  • Northwest Gastroenerology Associates

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Seattle Gastroenterology Associates

    Seattle, Washington 98133
    United States

    Site Not Available

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