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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00209300 |
This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.
Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).
Number of Subjects (Planned and Analysed):
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: Pentasa |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-Centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Markus Krankenhaus, Frankfurte Diakonie Kliniken, Frankfurt, Germany | |
Berlin, Germany |
Principal Investigator: | Axel U. Dignass, Dr. Prof | Markus Krankenhaus, Frankfurter Diakonie Kliniken, Frankfurt, Germany |
Study ID Numbers: | FE999907, CS0003, 2004-004565-15 |
Study First Received: | September 13, 2005 |
Last Updated: | August 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00209300 |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Ulcerative Colitis for Maintenance of Remission |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Pharmacologic Actions |