Prevention of Recurrence of Diverticulitis
- Conditions
- Diverticulitis
- Interventions
- Drug: SPD476, MMX™ mesalazine, 1.2g extended release tabletDrug: SPD476, MMX™ mesalazine, 2.4g extended release tabletDrug: SPD476, MMX™ mesalazine, 4.8g extended release tabletDrug: Placebo
- Registration Number
- NCT00545103
- Lead Sponsor
- Shire
- Brief Summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 592
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPD476 (1.2 g) SPD476, MMX™ mesalazine, 1.2g extended release tablet - SPD476 (2.4 g) SPD476, MMX™ mesalazine, 2.4g extended release tablet - SPD476 (4.8 g) SPD476, MMX™ mesalazine, 4.8g extended release tablet - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percent of Subjects Without Recurrence of Diverticulitis up to 104 Weeks 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
Name Time Method Percent of Subjects Requiring Surgery for Diverticulitis up to 104 Weeks Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis up to 104 weeks 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 up to 104 Weeks 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 up to 104 weeks 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 up to 104 weeks 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 up to 104 weeks 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.
Trial Locations
- Locations (125)
Digestive Disorders Center
🇺🇸Pittsburgh, Pennsylvania, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Seattle Gastroenterology Associates
🇺🇸Seattle, Washington, United States
Atlanta Gastroenterology Associates
🇺🇸Marietta, Georgia, United States
High Desert Gastroenterology, Inc.
🇺🇸Lancaster, California, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Medical Affiliated Research Center, Inc
🇺🇸Huntsville, Alabama, United States
Sunflower Medical Group
🇺🇸Mission, Kansas, United States
CA Physicians Research Alliance
🇺🇸Oceanside, California, United States
Kansas Medical Clinic
🇺🇸Topeka, Kansas, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Gastroenterology Centre
🇨🇦Pointe-Claire, Quebec, Canada
Houston Endoscopy and Research Center
🇺🇸Houston, Texas, United States
Kuopio University Hospital
🇫🇮Kuopio, Finland
Päijat-Häme Central Hospital
🇫🇮Lahti, Finland
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Digestive Care Medical Center
🇺🇸San Carlos, California, United States
Centro de Pesquisas Clinicas- CPCLIN
🇧🇷Sao Paulo, Brazil
Gastrointestinal Associates, PA
🇺🇸Jackson, Mississippi, United States
Madeleine DuPree, MD
🇺🇸Boynton Beach, Florida, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Digestive Disease Consultants
🇺🇸Maitland, Florida, United States
Mark Lamet, MD
🇺🇸Hollywood, Florida, United States
Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Q&T Research
🇨🇦Sherbrooke, Quebec, Canada
University of Miami
🇺🇸Miami, Florida, United States
Arapahoe Gastroenterology, PC
🇺🇸Littleton, Colorado, United States
Maryland Clinical Trials
🇺🇸Annapolis, Maryland, United States
Liver and Intestinal Research Centre
🇨🇦Vancouver, British Columbia, Canada
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.
🇧🇷Goiania, GO, Brazil
The Gastroenterology Group of South Jersey
🇺🇸Vineland, New Jersey, United States
NY Center for Clinical Research
🇺🇸Lake Success, New York, United States
Fundacao Universidade Federal do Rio Grande - Hopsital Universitario
🇧🇷Rio Grande, RS, Brazil
LeBauer Research Associates, PA
🇺🇸Greensboro, North Carolina, United States
Shah Associates, LLC
🇺🇸Prince Frederick, Maryland, United States
Cleveland Clinic Canada
🇨🇦Toronto, Ontario, Canada
Center for Digestive & Liver Diseases, Inc
🇺🇸Mexico, Missouri, United States
Digestive Specialists Inc.
🇺🇸Dayton, Ohio, United States
Gastrointestinal Clinical of Quad Cities
🇺🇸Davenport, Iowa, United States
Charm City Research, LLC
🇺🇸Lutherville, Maryland, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Concorde Medical Group
🇺🇸New York, New York, United States
Hospital Universitario Pedro Ernesto
🇧🇷Rio de Janeiro, Brazil
Memphis Gastroenterology Group, PC
🇺🇸Germantown, Tennessee, United States
Physician Research Options
🇺🇸Murray, Utah, United States
Suomen Terveystalo Oyj
🇫🇮Jyvaskyla, Finland
Topsail Road Medical Clinic
🇨🇦St John's, Newfoundland and Labrador, Canada
Ospedale Valduce
🇮🇹Como, Italy
Peterfy Hospital, Dept. Of Gastroenterology
🇭🇺Budapest, Hungary
University of Debrecen, 3rd Dept. Of Medicine
🇭🇺Debrecen, Hungary
St. Jans Gashuis
🇳🇱Weert, Netherlands
Kaposi Mór Teaching Hospital
🇭🇺Kaposvár, Hungary
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Ikazia Ziekenhuis
🇳🇱Rotterdam, Netherlands
Oulu University Hospital
🇫🇮Oulu, Finland
Policlinico Univeritario A. Gemelli
🇮🇹Roma, Italy
Milpark Hospital
🇿🇦Johannesburg, South Africa
Johannesburg General Hospital
🇿🇦Johannesburg, South Africa
Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne
🇩🇪Herne, Nord-Rhein-Wesfalen, Germany
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
🇭🇺Gyula, Hungary
Karolina Hospital, Dept. of Internal Medicine and Gastroenterology
🇭🇺Mosonmagyaróvár, Hungary
Centrul Medical Galenus
🇷🇴Targu Mures, Romania
Ospedale Fatebenefratelli ed Oftalmico
🇮🇹Milano, Italy
Kloof Medi-Clinic
🇿🇦Pretoria, South Africa
Panorama Medi-Clinic
🇿🇦Cape Town, South Africa
Synexus ClinPharm International GmbH
🇩🇪Potsdam, Germany
Synexus ClinPharm GmbH Berlin
🇩🇪Berlin, Berlin (Hellersdorf), Germany
Policlinico Univeritario A Gemelli
🇮🇹Roma, Italy
Universitas Hospital
🇿🇦Bloemfontein, South Africa
Harold Bloch
🇿🇦Cape Town, South Africa
Kingsbury Hospital
🇿🇦Cape Town, South Africa
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Policlinica "Dr. Citu" SRL
🇷🇴Timisoara, Romania
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
🇮🇹Roma, Italy
San Camillo Forlanini
🇮🇹Roma, Italy
Spitalul Universitar de Urgenta Bucuresti
🇷🇴Bucharest, Romania
Cabinet Particular Policlinic Algomed SRL
🇷🇴Timisoara, Romania
Chelmsford Medical Centre 2
🇿🇦Durban, South Africa
Louis Leipoldt Medical Centre
🇿🇦Cape Town, South Africa
Parklands Medical Centre
🇿🇦Durban, South Africa
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Hidalgo Clinical Research
🇺🇸San Antonio, Texas, United States
Rider Research Group
🇺🇸San Francisco, California, United States
Vaasa Central Hospital
🇫🇮Vaasa, Finland
Spitalul Clinic "Dr. I. Cantacuzino"
🇷🇴Bucharest, Romania
Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat
🇭🇺Vác, Hungary
CMI de Gastroenterologie Dobru Daniela
🇷🇴Targu Mures, Mures, Romania
Universita degli Studi di Padova
🇮🇹Padova, Italy
Hospital Sao Lucas PUCRS
🇧🇷Porto Alegre, RS, Brazil
Unidade Integrada de Gastroenterologia UNIGASTRO
🇧🇷Campinas, SP, Brazil
Omnispec Clinical Research
🇨🇦Mirabel, Quebec, Canada
Linksfield Park Clinic
🇿🇦Johannesburg, South Africa
Digestive and Liver Disease Specialists
🇺🇸Garden Grove, California, United States
Huntington Medical Foundation
🇺🇸San Marino, California, United States
Litchfield County Gastroenterology Associates, LLC
🇺🇸Torrington, Connecticut, United States
Palmetto Research LLC
🇺🇸Hialeah, Florida, United States
Clinical Research of the Rockies
🇺🇸Lafayette, Colorado, United States
United Medical Research
🇺🇸New Smyrna Beach, Florida, United States
Mid Atlantic Medical Research Centers
🇺🇸Hollywood, Maryland, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
AMH Feasterville Family Health Care Center
🇺🇸Feasterville, Pennsylvania, United States
Hospital Universitário Clementino Fraga Filho
🇧🇷Rio de Janeiro, RJ, Brazil
Northwest Gastroenerology Associates
🇺🇸Bellevue, Washington, United States
Universidade Federal de Juiz de Fora
🇧🇷Juiz de Fora, MG, Brazil
Corunna Medical Research Centre
🇨🇦Corunna, Ontario, Canada
Irmandade da Santa Casa de Misericordia de Santos
🇧🇷Santos, Sao Paolo, Brazil
Hotel-Dieu de Levis
🇨🇦Levis, Quebec, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina
🇮🇹Pavia, Italy
U.O. di Gastroenterologia ed Endoscopia digestiva Torre delle Medicine Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Birmingham Gastroenterology Associates, PC
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
West Wind'r Research & Development
🇺🇸Tampa, Florida, United States
Digestive Health Specialists
🇺🇸Winston-Salem, North Carolina, United States
Alabama Digestive Disorders Center, PC
🇺🇸Huntsville, Alabama, United States
Granite Peaks Gastroenterology
🇺🇸Sandy, Utah, United States