A Study With Pentasa in Patients With Active Crohn's Disease
NCT ID: NCT00862121
Last Updated: 2012-03-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
20 participants
INTERVENTIONAL
2009-04-30
2010-10-31
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
TREATMENT
DOUBLE
Study Groups
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Mesalazine
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
Pentasa
6 g/day orally, 2 g in the morning and 4 g in the evening
Placebo
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
Placebo
6 g/day orally, 2 g in the morning and 4 g in the evening
Interventions
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Pentasa
6 g/day orally, 2 g in the morning and 4 g in the evening
Placebo
6 g/day orally, 2 g in the morning and 4 g in the evening
Eligibility Criteria
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Inclusion Criteria
* CD symptoms/onset of disease: ≥ 3 months prior to Visit 1
* Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
* A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy)
* A Harvey-Bradshaw score between 5 and 12
* Males and non-pregnant, non-nursing women
* Mild to moderate active CD, defined by a CDAI score between 180 and 350
* Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g)
* Estimated creatinine clearance should be above 75 ml/min
Exclusion Criteria
* CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease
* Prior treatment resistance to Pentasa (mesalazine)
* Chronic, dominant arthralgia or rheumatoid arthritis
* Palpable abdominal mass
* Biologics (eg anti-TNF-α) must not be used during the trial or 6 months before Visit 1
* Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
* Positive pregnancy test
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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San Diego Clinical Trials
San Diego, California, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Atlanta Gastroenterology Specialists
John's Creek, Georgia, United States
Center for Digestive and Liver Disease, Inc
Mexico, Montana, United States
Wake Research Associates
Raleigh, North Carolina, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States
Hartwell Research Group, LLC
Anderson, South Carolina, United States
CHC Saint Joseph
Liège, , Belgium
Herlev University Hospital
Copenhagen, , Denmark
Investigational Site
Lille, , France
Investigational Site
Berlin, , Germany
Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln
Cologne, , Germany
Gemeinschaftspraxis
Leipzig, , Germany
Lunds Lasaret
Lund, , Sweden
Addenbrookes Hospital
Cambridge, , United Kingdom
Countries
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Other Identifiers
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EudraCT no: 2008-002100-26
Identifier Type: -
Identifier Source: secondary_id
FE999907 CS05
Identifier Type: -
Identifier Source: org_study_id
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