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Sponsored by: |
Dr. Falk Pharma GmbH |
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Information provided by: | Dr. Falk Pharma GmbH |
ClinicalTrials.gov Identifier: | NCT00747110 |
The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.
Condition | Intervention | Phase |
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Colitis, Ulcerative |
Drug: budesonide Drug: mesalazine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Double-Blind, Double-Dummy, Randomised, Multi-Centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis |
Enrollment: | 343 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
9mg budesonide OD
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Drug: budesonide
3x 3mg budesonide capsules once daily
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B: Active Comparator
3g mesalazine OD
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Drug: mesalazine
3x 1000mg mesalazine onc daily
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Dr. Falk Pharma GmbH ( Dr. Ralph Mueller - Project Manager Clinical Research & Development ) |
Study ID Numbers: | BUC-57/UCA, EudraCT No.: 2006-005377-22 |
Study First Received: | September 3, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00747110 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
5-ASA mesalamine mesalazine budesonide ulcerative colitis |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases Budesonide |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Respiratory System Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Glucocorticoids Hormones Pharmacologic Actions Pathologic Processes Sensory System Agents |
Analgesics, Non-Narcotic Autonomic Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Bronchodilator Agents |