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Clinical Trial Name -Treatment of Microscopic Colitis
| Original Study ID : SLV 01-07035 |
| NCT ID : NCT00184171 |
| Brief Title : Treatment of Microscopic Colitis |
| Official Title : Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber |
| Brief Summary : The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis |
| Source : Norwegian University of Science and Technology |
| Detailed Description : This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphcocytic colitis). |
| Overall Status : Completed |
| Start Date : November 2001 |
| End Date : September 2007 |
| Completion Date : September 2007 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Enrollment : 168 |
| Verification Date : February 2008 |
| First Received Date : September 10, 2005 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - Microscopic colitis verified with biopsies from the colon - Symptoms to such an extent that treatment is indicated - Age > 17 years - Informed consent Exclusion Criteria: - Previous treatment with any of the investigational drugs - Patients treated with ketoconazole - Pregnant and breast-feeding females |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : St. Olavs Hospital |
| City : Trondheim |
| Zip Code : 7006 |
| Country : Norway |
| Facility Name : Rikshopitalet |
| City : Oslo |
| Zip Code : 7006 |
| Country : Norway |
| Facility Name : Aker sykehus |
| City : Oslo |
| Zip Code : 7006 |
| Country : Norway |
| Facility Name : Sykehuset Innlandet HF, Gjøvik |
| City : Gjovik |
| Zip Code : 2819 |
| Country : Norway |
| Facility Name : Akershus Universitetssykehus |
| City : Nordbyhagen |
| Zip Code : 2819 |
| Country : Norway |
| Facility Name : Sykehuset Innlandet, HF, Hamar |
| City : Hamar |
| Zip Code : 2819 |
| Country : Norway |
| Facility Name : Sykehuset Innlandet HF, Lillehammer |
| City : Lillehammer |
| Zip Code : 2819 |
| Country : Norway |
| Facility Name : Helse NordMøre og Romsdal |
| City : Molde |
| Zip Code : 2819 |
| Country : Norway |
| Facility Name : Aust-Agder Sentralsjukehus |
| City : Arendal |
| Zip Code : 2819 |
| Country : Norway |
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