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Sponsored by: |
Dr. Falk Pharma GmbH |
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Information provided by: | Dr. Falk Pharma GmbH |
ClinicalTrials.gov Identifier: | NCT00300118 |
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Drug: budesonide Drug: mesalazine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Double-Dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients |
Enrollment: | 311 |
Study Start Date: | September 2004 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: budesonide
9 mg
|
B: Active Comparator |
Drug: mesalazine
4.5 g
|
Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are indicated for active Crohn's disease. Treatment with mesalazine is indicated for the treatment of mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine 4.5 g/day are better than lower doses.
So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of this trial is that budesonide is more effective in inducing remission than mesalazine. The primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease. Mesalazine is used in this trial as a comparator.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (main):
Exclusion Criteria (main):
Study ID Numbers: | BUC-52/CDA, 2004-001213-34 |
Study First Received: | March 7, 2006 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00300118 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Crohn Disease |
Budesonide Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |
Anti-Inflammatory Agents Respiratory System Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Glucocorticoids Hormones Pharmacologic Actions 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 |