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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00630942 |
The purpose of the study is to see how safe and effective minocycline is in the treatment of Primary Sclerosing Cholangitis (PSC).
Condition | Intervention | Phase |
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Primary Sclerosing Cholangitis |
Drug: Minocycline |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Single Group Assignment |
Official Title: | Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC) |
Enrollment: | 16 |
Study Start Date: | February 2003 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Arm, active treatment: Experimental |
Drug: Minocycline
Minocycline 100 mg capsules twice a day before breakfast and before dinner.
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The purpose of the study is to determine the safety profile of minocycline in patients with PSC and to compare the effects of minocycline on the baseline values of the following parameters: symptoms of pruritus and fatigue, liver biochemistries, Mayo Risk Score, the development of clinical progression and complications of liver disease.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mayo Clinic ( Dr. Keith D. Lindor, M.D. ) |
Study ID Numbers: | 1559-02 |
Study First Received: | February 27, 2008 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00630942 |
Health Authority: | United States: Food and Drug Administration |
PSC |
Minocycline Primary sclerosing cholangitis Cholangitis Digestive System Diseases |
Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |