Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
590 participants
INTERVENTIONAL
2007-11-28
2012-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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SPD476 (1.2 g)
SPD476 (1.2g)
1.2g SPD476 once daily (QD) orally
SPD476 (2.4 g)
SPD476 (2.4 g)
2.4g SPD476 QD orally
SPD476 (4.8 g)
SPD476 (4.8 g)
4.8g SPD476 QD orally
Placebo
Placebo
QD orally
Interventions
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SPD476 (1.2g)
1.2g SPD476 once daily (QD) orally
SPD476 (2.4 g)
2.4g SPD476 QD orally
SPD476 (4.8 g)
4.8g SPD476 QD orally
Placebo
QD orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Dedicated Clinical Research
Litchfield Park, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
GW Research
Chula Vista, California, United States
Monterey Bay GI Research Institute, Inc
Monterey, California, United States
Rancho Cucamonga C. Trials
Rancho Cucamonga, California, United States
Clinical Trials Research
Roseville, California, United States
Medical Associates Research
San Diego, California, United States
Torrance Clinical Research
Torrance, California, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
ZASA Clinical Research
Boynton Beach, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Compass Research
Orlando, Florida, United States
Accord Clinic Research, LLC
Port Orange, Florida, United States
Florida Medical Clinic/Tampa Clinical Trials
Tampa, Florida, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
Saint John's Research Institute
Anderson, Indiana, United States
Digestive & Liver Disease Consultants
Clive, Iowa, United States
New Orleans Research Institute
Metairie, Louisiana, United States
Digestive Disease Associates
Baltimore, Maryland, United States
Endoscopic Microsurgery Associates, PA
Towson, Maryland, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
South Jersey Gastroenterology, P.A.
Marlton, New Jersey, United States
Howard Guss, DO
Ocean City, New Jersey, United States
New Jersey Physicians, LLC
Passaic, New Jersey, United States
Allied Gastrointestinal Associates, P.A.
Voorhees Township, New Jersey, United States
Regional Clinical Research
Endwell, New York, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
Research Associates of New York
New York, New York, United States
Vital Research
Greensboro, North Carolina, United States
Gastroenterology Specialists, Inc
Canton, Ohio, United States
Memorial Research Center
Chattanooga, Tennessee, United States
Gastroenterology Associates Clinical Research
Kingsport, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Harris Methodist Fort Worth Hospital
Fort Worth, Texas, United States
Kelsey-Seybold Clinic
Houston, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Stone Oak Research Foundation
San Antonio, Texas, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Aurora Advanced Healthcare, Inc. - Clinical Research Center
Milwaukee, Wisconsin, United States
CIMEL
Lanús, Buenos Aires, Argentina
Instituto Gamma
Rosario, Santa Fe Province, Argentina
Hospital Bocalandro
Buenos Aires, , Argentina
Hospital Heroes de Malvinas
Buenos Aires, , Argentina
GEDYT
Buenos Aires, , Argentina
Sanatorio Guemes
Buenos Aires, , Argentina
Cibic S.A.
Santa Fe, , Argentina
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Ballarat Base Hospital
Ballarat, Victoria, Australia
St Vincent's Hospital (Melb) LTD
Melbourne, Victoria, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Royal Prince Albert Hospital
Camperdown, , Australia
Frankston Private
Frankston, , Australia
Bayside Gastroenterology
Frankston, , Australia
Fremantle Hospital
Fremantle, , Australia
Ugasend S.A
Barranquilla, , Colombia
Clinica Colsinatas SA
Bogotá, , Colombia
FOQUS, Centro de Investigacion Clinica
Bogotá, , Colombia
Fundacion Clinica Abood Shaio
Bogotá, , Colombia
Hospital Universitario San Ignacio
Bogotá, , Colombia
Clinica Las Americas
Medellín, , Colombia
CHU de Strasbourg
Strasbourg, Alsace, France
CHU de Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Hepato Gastro Enterology
Nantes, Brittany Region, France
Hopital Charles Nicolle
Rouen, Normandy, France
Hopital Beaujon
Clichy, Paris, France
Cabinet de Gastro-enterologie du Dr Alain Thevenin
Saint-Quentin, Picardie, France
Clinique Bouchard
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hopital I'Archet
Nice, Provence-Alpes-Côte d'Azur Region, France
Cabinet du Dr Olivier Delette
Lille, , France
Dr Michel Regensberg
Paris, , France
Baby Memorial Hospital
Calicut, Kerala, India
Lakeshore Hospital & Research Centre Ltd
Kochi, Kerala, India
Sree Gokulam Medical College and Research Foundation
Trivandrum, Kerala, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, India
S R Kalla Memorial Hospital
Jaipur, Rajasthan, India
Aceer
Chennai, Tamil Nadu, India
Institute of Postgraduate Medical Education and Research
Kolkata, West Bengal, India
Brahmin Mitra Mandal Society
Ahmedabad, , India
Ruby Hall Clinic
Pune, , India
Krishna Institute of Medical Sciences
Secunderabad, , India
Emek Medical Center
Afula, , Israel
Barzilai Medical Centre
Ashkelon, , Israel
Soroka Medical Center
Beersheba, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah Ein-Karem Medical Center
Jerusalem, , Israel
Meir Medical Centre
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Shakespeare Specialist Group
Takapuna, Auckland, New Zealand
Auckland City Hospital
Auckland, , New Zealand
CURT Medical Trials Trust Board
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Hospital Valle de Hebron
Barcelona, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital de Donostia
Donostia / San Sebastian, , Spain
Hospital Son Dureta
Palma de Mallorca, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
University Hospital/Eastern Hospital
Gothenburg, , Sweden
University Hospital Linköping
Linköping, , Sweden
VO Internmedicin
Stockholm, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Danderyd Hospital
Stockholm, , Sweden
Kirurgkliniken
Uppsala, , Sweden
Norfolk/Norwich University Hospital
Norwich, East Anglia, United Kingdom
St Mark's Hospital
Harrow, London, United Kingdom
King's College Hospital
London, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
Imperial College London
London, , United Kingdom
Countries
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References
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Raskin JB, Kamm MA, Jamal MM, Marquez J, Melzer E, Schoen RE, Szaloki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.
Other Identifiers
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2007-004895-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD476-313
Identifier Type: -
Identifier Source: org_study_id
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