Prevention of Recurrence of Diverticulitis

Condition(s) targeted: Diverticulitis

Intervention: SPD476, MMX™ mesalazine, 1.2g extended release tablet (Drug); SPD476, MMX™ mesalazine, 1.2g extended release tablet (Drug); SPD476, MMX™ mesalazine, 1.2g extended release tablet (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Shire Pharmaceutical Development

Official(s) and/or principal investigator(s):
Jeffrey B. Raskin, M.D., Principal Investigator, Affiliation: University of Miami Miller School of Medicine

Overall contact:
Shire Call Centre, Phone: +1 866 842 5335

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

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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Changes in predefined lab parameters

Time to presence of predefined symptoms of diverticulitis

Secondary outcome:

Proportion of subjects without recurrence of diverticulitis between 3 doses of SPD476 and placebo

Evaluate the subgroup classifications of diverticulitis between 3 doses of SPD476 and placebo

Proportion of subjects requiring surgical intervention for diverticular disease up to 104 weeks post baseline between 3 doses of SPD476 and placebo

Quality of Life (QoL)questionnaires between treatment groups

To assess the safety and tolerability of SPD476 at 3 different doses

Endoscopy of the sigmoid colon between treatment groups

Histology of biopsy samples between treatment groups

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Shire Call Centre, Phone: +1 866 842 5335

Hospital Universitario Pedro Ernesto, Rio de Janeiro 20551-030, Brazil; Recruiting

Centro de Pesquisas Clinicas- CPCLIN, Sao Paulo 01244-030, Brazil; Not yet recruiting

Oulu University Hospital, Oulu 90220, Finland; Recruiting

Kuopio University Hospital, Kuopio 70211, Finland; Withdrawn

Vaasa Central Hospital, Vaasa 65130, Finland; Withdrawn

Suomen Terveystalo Oyj, Jyvaskyla 40100, Finland; Recruiting

Päijat-Häme Central Hospital, Lahti 15850, Finland; Recruiting

ClinPharm International GmbH, Potsdam 14467, Germany; Recruiting

ClinPharm International GmbH, Leipzig 04103, Germany; Recruiting

ClinPharm International GmbH, Chemnitz 09120, Germany; Not yet recruiting

Universitätsklinikum Schleswig-Holstein, Kiel 24105, Germany; Recruiting

ClinPharm International GmbH, Bochum 44787, Germany; Recruiting

ClinPharm International GmbH, Dresden 01067, Germany; Not yet recruiting

ClinPharm International GmbH, Frankfurt 60596, Germany; Recruiting

ClinPharm International GmbH, Magdeburg 39104, Germany; Recruiting

ClinPharm International GmbH, Görlitz 02826, Germany; Recruiting

Karolina Hospital, Dept. of Internal Medicine and Gastroenterology, Mosonmagyaróvár 9200, Hungary; Recruiting

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium, Gyula H-5700, Hungary; Recruiting

University of Debrecen, 3rd Dept. Of Medicine, Debrecen H-4032, Hungary; Recruiting

Kaposi Mór Teaching Hospital, Kaposvár H-7400, Hungary; Recruiting

Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat, Vác 2600, Hungary; Recruiting

San Camillo Forlanini, Roma 00151, Italy; Recruiting

Policlinico Univeritario A. Gemelli, Roma 00168, Italy; Not yet recruiting

Ospedale Valduce, Como 22100, Italy; Recruiting

Azienda Ospedaliera di Padova, Padova 35128, Italy; Recruiting

Ospedale Fatebenefratelli Corso di Porta Nuova, Milano 20121, Italy; Recruiting

Ospedale di Parma - Sezione di Gastroenterologia, Parma 43100, Italy; Not yet recruiting

Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina, Pavia 27100, Italy; Recruiting

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma 00133, Italy; Recruiting

Università Cattolica del Sacro Cuore, Roma 00168, Italy; Recruiting

Policlinico Universitario A. Gemelli di Roma, Roma 00168, Italy; Not yet recruiting

Academisch Ziekenhuis Maastricht, Maastricht 6202, Netherlands; Recruiting

Meander Medisch Centrum, Amersfoort 3816, Netherlands; Recruiting

Ikazia Ziekenhuis, Rotterdam 3083, Netherlands; Recruiting

VU Medisch Centrum, Amsterdam 1081 HV, Netherlands; Recruiting

St. Jans Gashuis, Weert 6001 BE, Netherlands; Recruiting

Spitalul Universitar de Urgenta Bucuresti, Bucharest 050098, Romania; Recruiting

Policlinica "Dr. Citu" SRL, Timisoara 300593, Romania; Recruiting

Cabinet Particular Policlinic Algomed SRL, Timisoara 300002, Romania; Recruiting

Institutul Clinic Fundeni, Bucharest 022328, Romania; Recruiting

Spitalul Clinic "Dr. I. Cantacuzino", Bucharest 020475, Romania; Recruiting

Centrul Medical Galenus, Tirgu Mures 540098, Romania; Recruiting

Panorama Medi-Clinic, Cape Town 7500, South Africa; Recruiting

Kingsbury Hospital, Cape Town 7708, South Africa; Recruiting

Harold Bloch, Cape Town 7130, South Africa; Recruiting

Louis Leipoldt Medical Centre, Cape Town 7530, South Africa; Recruiting

Parklands Medical Centre, Durban 4001, South Africa; Recruiting

Universitas Hospital, Bloemfontein 9300, South Africa; Recruiting

Linksfield Park Clinic, Johannesburg 2192, South Africa; Recruiting

Johannesburg General Hospital, Johannesburg 2193, South Africa; Recruiting

Milpark Hospital, Johannesburg 2006, South Africa; Recruiting

Kloof Medi-Clinic, Pretoria 0143, South Africa; Recruiting

St Augustine Medical Centre, Durban, South Africa; Recruiting

Medical Affiliated Research Center, Inc, Huntsville, Alabama 35801, United States; Recruiting

Alabama Digestive Disorders Center, PC, Huntsville, Alabama 35802, United States; Recruiting

Birmingham Gastroenterology Associates, PC, Birmingham, Alabama 35209, United States; Recruiting

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama 35235, United States; Recruiting

Genova Clinical Research, Tucson, Arizona 85741, United States; Recruiting

ClinPharm Berlin, Berlin, Berlin (Hellersdorf) 12627, Germany; Recruiting

Liver and Intestinal Research Centre, Vancouver, British Columbia V5Z 1H2, Canada; Recruiting

Digestive and Liver Disease Specialists, Garden Grove, California 92840, United States; Recruiting

CA Physicians Research Alliance, Oceanside, California 92083, United States; Withdrawn

Digestive Care Medical Center, San Carlos, California 94070, United States; Recruiting

Rider Research Group, San Francisco, California 94117, United States; Withdrawn

VA Long Beach Healthcare System, Long Beach, California 90822, United States; Recruiting

High Desert Gastroenterology, Inc., Lancaster, California 93534, United States; Recruiting

Huntington Medical Foundation, San Marino, California 91108, United States; Recruiting

Arapahoe Gastroenterology, PC, Littleton, Colorado 80120, United States; Recruiting

Clinical Research of the Rockies, Lafayette, Colorado 80026, United States; Recruiting

Litchfield County Gastroenterology Associates, LLC, Torrington, Connecticut 06790, United States; Recruiting

Digestive Disease Consultants, Maitland, Florida 32751, United States; Recruiting

United Medical Research, New Smyrna Beach, Florida 32168, United States; Recruiting

University of Miami, Miami, Florida 33136, United States; Not yet recruiting

Miami Research Associates, Miami, Florida 33143, United States; Recruiting

West Wind'r Research & Development, Tampa, Florida 33607, United States; Recruiting

Madeleine DuPree, MD, Boynton Beach, Florida 33426, United States; Recruiting

Digestive Medicine Associates, Hialeah, Florida 33016, United States; Recruiting

University of Miami Miller School of Medicine, Miami, Florida 33136, United States; Not yet recruiting

Mark Lamet, MD, Hollywood, Florida 33021, United States; Recruiting

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda., Goiania, GO 74535-170, Brazil; Recruiting

Atlanta Gastroenterology Associates, Marietta, Georgia 30067, United States; Recruiting

Gastrointestinal Clinical of Quad Cities, Davenport, Iowa 52807, United States; Recruiting

Sunflower Medical Group, Mission, Kansas 66202, United States; Recruiting

Kansas Medical Clinic, Topeka, Kansas 66606, United States; Recruiting

Gastroenterology Associates, LLC, Baton Rouge, Louisiana 70809, United States; Recruiting

Louisiana Research Center, LLC, Shreveport, Louisiana 71103, United States; Recruiting

Mid Atlantic Medical Research Centers, Hollywood, Maryland 20636, United States; Recruiting

Charm City Research, LLC, Lutherville, Maryland 21093, United States; Recruiting

Maryland Clinical Trials, Annapolis, Maryland 21401, United States; Withdrawn

Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, United States; Recruiting

Shah Associates, LLC, Prince Frederick, Maryland 20678, United States; Recruiting

Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan 48047, United States; Recruiting

Center for Digestive Health, Troy, Michigan 48098, United States; Recruiting

Gastrointestinal Associates, PA, Jackson, Mississippi 39202, United States; Recruiting

Center for Digestive & Liver Diseases, Inc, Mexico, Missouri 65265, United States; Recruiting

Sundance Clinical Research, St Louis, Missouri 63141, United States; Recruiting

CMI de Gastroenterologie Dobru Daniela, Tirgu Mures, Mures 540461, Romania; Recruiting

The Gastroenterology Group of South Jersey, Vineland, New Jersey 08360, United States; Recruiting

NY Center for Clinical Research, Lake Success, New York 11042, United States; Recruiting

Concorde Medical Group, New York, New York 10016, United States; Recruiting

Topsail Road Medical Clinic, St John's, Newfoundland and Labrador A1E 2E2, Canada; Recruiting

Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne, Herne, Nord-Rhein-Wesfalen 44623, Germany; Recruiting

Cumberland Research Associates, Fayetteville, North Carolina 28304, United States; Recruiting

Wake Research Associates, Raleigh, North Carolina 27612, United States; Recruiting

Digestive Health Specialists, Winston-Salem, North Carolina 27103, United States; Recruiting

LeBauer Research Associates, PA, Greensboro, North Carolina 27403, United States; Recruiting

Dayton Science Institute, Dayton, Ohio 45415, United States; Recruiting

Consultants for Clinical Research, Cincinnati, Ohio 45219, United States; Recruiting

Sunnybrook, Toronto, Ontario M4N 3M5, Canada; Not yet recruiting

Cleveland Clinic Canada, Toronto, Ontario M5J 2T3, Canada; Recruiting

Corunna Medical Research Centre, Corunna, Ontario N0N 1G0, Canada; Not yet recruiting

AMH Feasterville Family Health Care Center, Feasterville, Pennsylvania 19053, United States; Recruiting

Digestive Disorders Center, Pittsburgh, Pennsylvania 15213, United States; Recruiting

Recherche Clinique, Montreal, Quebec H1T 2M4, Canada; Not yet recruiting

Omnispisc Clinical Research, Mirabel, Quebec J7J 2K8, Canada; Recruiting

Hotel-Dieu de Levis, Levis, Quebec G6V 3Z1, Canada; Recruiting

Hopital Maisonneuve-Rosemont, Montreal, Quebec H1T 2M4, Canada; Recruiting

Q&T Research, Sherbrooke, Quebec J1H4J6, Canada; Recruiting

Gastroenterology Centre, Pointe-Claire, Quebec H9R 3J1, Canada; Recruiting

Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, RJ 21.941-913, Brazil; Not yet recruiting

Fundacao Universidade Federal do Rio Grande - Hopsital Universitario, Rio Grande, RS 96200-310, Brazil; Not yet recruiting

Hospital Sao Lucas PUCRS, Porto Alegre, RS Porto Alegre, Brazil; Recruiting

Hospital de Clinicas de Porto Alegre, Porto Alegre, RS 90035-003, Brazil; Not yet recruiting

Unidade Integrada de Gastroenterologia UNIGASTRO, Campinas, SP 13070-040, Brazil; Recruiting

Irmandade da Santa Casa de Misericordia de Santos, Santos, Sao Paulo 11075-900, Brazil; Not yet recruiting

Clinsearch, LLC, Chattanooga, Tennessee 37404, United States; Recruiting

Memphis Gastroenterology Group, PC, Germantown, Tennessee 38138, United States; Recruiting

Houston Endoscopy and Research Center, Houston, Texas 77024, United States; Recruiting

Hidalgo Clinical Research, San Antonio, Texas 78215, United States; Recruiting

Granite Peaks Gastroenterology, Sandy, Utah 84094, United States; Recruiting

Colon and Rectal Disease Center, Murry, Utah 84070, United States; Recruiting

Northwest Gastroenerology Associates, Bellevue, Washington 98004, United States; Recruiting

Seattle Gastroenterology Associates, Seattle, Washington 98133, United States; Recruiting

Universidade Federal de Juiz de Fora, Juiz de Fora, mg 36036-330, Brazil; Not yet recruiting

Starting date: December 2007
Ending date: February 2011
Last updated: October 6, 2009