Prevention of Recurrence of Diverticulitis

Last updated: June 8, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Intra-abdominal Infections

Treatment

N/A

Clinical Study ID

NCT00545740
SPD476-313
2007-004895-37
  • 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: 590
Study Start date:
November 28, 2007
Estimated Completion Date:
March 05, 2012

Connect with a study center

  • CIMEL

    Lanus, Buenos Aires B1824KAS
    Argentina

    Site Not Available

  • Instituto Gamma

    Rosario, Santa Fe S2000DFD
    Argentina

    Site Not Available

  • GEDYT

    Buenos Aires, C1117AAA
    Argentina

    Site Not Available

  • Hospital Bocalandro

    Buenos Aires, B1657BHD
    Argentina

    Site Not Available

  • Hospital Heroes de Malvinas

    Buenos Aires, B1722FJN
    Argentina

    Site Not Available

  • Sanatorio Guemes

    Buenos Aires, C1180AAX
    Argentina

    Site Not Available

  • Cibic S.A.

    Santa Fe, S2000BCG
    Argentina

    Site Not Available

  • The Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Ballarat Base Hospital

    Ballarat, Victoria 3350
    Australia

    Site Not Available

  • St Vincent's Hospital (Melb) LTD

    Melbourne, Victoria 3065
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • Royal Prince Albert Hospital

    Camperdown, 2050
    Australia

    Site Not Available

  • Bayside Gastroenterology

    Frankston, VIC 3199
    Australia

    Site Not Available

  • Frankston Private

    Frankston, 3199
    Australia

    Site Not Available

  • Fremantle Hospital

    Fremantle, 6160
    Australia

    Site Not Available

  • Ugasend S.A

    Barranquilla,
    Colombia

    Site Not Available

  • Clinica Colsinatas SA

    Bogota,
    Colombia

    Site Not Available

  • FOQUS, Centro de Investigacion Clinica

    Bogota,
    Colombia

    Site Not Available

  • Fundacion Clinica Abood Shaio

    Bogota,
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio

    Bogota,
    Colombia

    Site Not Available

  • Clinica Las Americas

    Medellin,
    Colombia

    Site Not Available

  • CHU de Strasbourg

    Strasbourg, Alsace 67200
    France

    Site Not Available

  • Hepato Gastro Enterology

    Nantes, Brittany 44033
    France

    Site Not Available

  • Hopital Charles Nicolle

    Rouen, Normandy 76031
    France

    Site Not Available

  • Hopital Beaujon

    Clichy, Paris 92118
    France

    Site Not Available

  • Cabinet de Gastro-enterologie du Dr Alain Thevenin

    Saint Quentin, Picardie 02100
    France

    Site Not Available

  • Hopital I'Archet

    Nice, Provence-Alpes-Côte d'Azur 06200
    France

    Site Not Available

  • Clinique Bouchard

    Marseille, Provence-Alpes-Côte-d'Azur 13000
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble, Rhone-Alpes 38043
    France

    Site Not Available

  • Cabinet du Dr Olivier Delette

    Lille, 59000
    France

    Site Not Available

  • Dr Michel Regensberg

    Paris, 75017
    France

    Site Not Available

  • Baby Memorial Hospital

    Calicut, Kerala 673004
    India

    Site Not Available

  • Lakeshore Hospital & Research Centre Ltd

    Cochin, Kerala 682304
    India

    Site Not Available

  • Sree Gokulam Medical College and Research Foundation

    Trivandrum, Kerala 695607
    India

    Site Not Available

  • Sree Gokulam Medical College and Research Foundation

    Venjaramoodu, Kerala 695607
    India

    Site Not Available

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab 141001
    India

    Site Not Available

  • S R Kalla Memorial Hospital

    Jaipur, Rajasthan
    India

    Site Not Available

  • Aceer

    Chennai, Tamil Nadu 600020
    India

    Site Not Available

  • Institute of Postgraduate Medical Education and Research

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Brahmin Mitra Mandal Society

    Ahmedabad, 380006
    India

    Site Not Available

  • Brahmin Mitra Mandal Society

    Gujarat, 380006
    India

    Site Not Available

  • Institute of Postgraduate Medical Education and Research

    Kolkatta, 700020
    India

    Site Not Available

  • Ruby Hall Clinic

    Pune, 411 001
    India

    Site Not Available

  • Krishna Institute of Medical Sciences

    Secunderabad, 500 003
    India

    Site Not Available

  • Emek Medical Center

    Afula, 18101
    Israel

    Site Not Available

  • Barzilai Medical Centre

    Ashkelon, 78278
    Israel

    Site Not Available

  • Soroka Medical Center

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 31048
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 63106
    Israel

    Site Not Available

  • Hadassah Ein-Karem Medical Center

    Jerusalem,
    Israel

    Site Not Available

  • Meir Medical Centre

    Kfar-Saba,
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rechovot,
    Israel

    Site Not Available

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Zerifin, 70300
    Israel

    Site Not Available

  • Shakespeare Specialist Group

    Takapuna, Auckland
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Auckland,
    New Zealand

    Site Not Available

  • CURT Medical Trials Trust Board

    Christchurch,
    New Zealand

    Site Not Available

  • Dunedin Hospital

    Dunedin,
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3240
    New Zealand

    Site Not Available

  • Tauranga Hospital

    Tauranga,
    New Zealand

    Site Not Available

  • Hospital Universitario de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Valle de Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Son Dureta

    Palma de Mallorca, 07014
    Spain

    Site Not Available

  • Hospital Virgen del Camino

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital de Donostia

    San Sebastian, 20014
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • University Hospital/Eastern Hospital

    Goteborg, 41685
    Sweden

    Site Not Available

  • University Hospital Linköping

    Linköping, 58185
    Sweden

    Site Not Available

  • University Hospital Linköping

    Linköping, 58185
    Sweden

    Site Not Available

  • Danderyd Hospital

    Stockholm, 18288
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm, 17176
    Sweden

    Site Not Available

  • VO Internmedicin

    Stockholm, 11883
    Sweden

    Site Not Available

  • Kirurgkliniken

    Uppsala,
    Sweden

    Site Not Available

  • Norfolk/Norwich University Hospital

    Norwich, East Anglia NR4 7UY
    United Kingdom

    Site Not Available

  • St Mark's Hospital

    Harrow, London HA1 3UJ
    United Kingdom

    Site Not Available

  • Chelsea & Westminster Hospital

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • Imperial College London

    London, W12 0NN
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Dedicated Clinical Research

    Litchfield Park, Arizona 85340
    United States

    Site Not Available

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Advanced Clinical Research Institute

    Anaheim, California 92108
    United States

    Site Not Available

  • GW Research

    Chula Vista, California 91910
    United States

    Site Not Available

  • Monterey Bay GI Research Institute, Inc

    Monterey, California 93940
    United States

    Site Not Available

  • Rancho Cucamonga C. Trials

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Clinical Trials Research

    Roseville, California 95661
    United States

    Site Not Available

  • Medical Associates Research

    San Diego, California 92123
    United States

    Site Not Available

  • Torrance Clinical Research

    Torrance, California 90505
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado 80229
    United States

    Site Not Available

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Yale Center for Clinical Investigation

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • ZASA Clinical Research

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Borland-Groover Clinic

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Compass Research

    Orlando, Florida 32806
    United States

    Site Not Available

  • Accord Clinic Research, LLC

    Port Orange, Florida 32129
    United States

    Site Not Available

  • Florida Medical Clinic/Tampa Clinical Trials

    Tampa, Florida 33613
    United States

    Site Not Available

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia 31201
    United States

    Site Not Available

  • Saint John's Research Institute

    Anderson, Indiana 46016
    United States

    Site Not Available

  • Digestive & Liver Disease Consultants

    Clive, Iowa 50325
    United States

    Site Not Available

  • New Orleans Research Institute

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Digestive Disease Associates

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Endoscopic Microsurgery Associates, PA

    Towson, Maryland 21204
    United States

    Site Not Available

  • Borgess Research Institute

    Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • South Jersey Gastroenterology, P.A.

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Howard Guss, DO

    Ocean, New Jersey 07712
    United States

    Site Not Available

  • Howard Guss, DO

    Ocean City, New Jersey 07712
    United States

    Site Not Available

  • New Jersey Physicians, LLC

    Passaic, New Jersey 07055
    United States

    Site Not Available

  • Allied Gastrointestinal Associates, P.A.

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Regional Clinical Research

    Endwell, New York 13760
    United States

    Site Not Available

  • Long Island Clinical Research Associates

    Great Neck, New York 11021
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group

    Great Neck, New York 11023
    United States

    Site Not Available

  • Research Associates of New York

    New York, New York 10075
    United States

    Site Not Available

  • Vital Research

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Gastroenterology Specialists, Inc

    Canton, Ohio 44718
    United States

    Site Not Available

  • Memorial Research Center

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Gastroenterology Associates Clinical Research

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Nashville Medical Research Institute

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Harris Methodist Fort Worth Hospital

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Kelsey-Seybold Clinic

    Houston, Texas 77005
    United States

    Site Not Available

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Stone Oak Research Foundation

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Aurora Advanced Healthcare, Inc. - Clinical Research Center

    Milwaukee, Wisconsin 53209
    United States

    Site Not Available

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