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A Study With Pentasa in Patients With Active Crohn's Disease - NCT00862121-(Clinical Trial 541554)



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City:  Salt Lake City
State:  
UT
Zip Code:
Conditions: Crohn´s Disease
Purpose: The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.
Study summary:
Criteria: Inclusion Criteria: - Age: at least 18 years - CD symptoms/onset of disease: ≥ 3 months prior 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 - Estimated creatinine clearance should be above 75 ml/min Exclusion Criteria: - Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial - 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) - 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
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Data Source: ClinicalTrials.gov
Date Processed: October 7, 2010
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