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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00059202 |
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.
Condition | Intervention | Phase |
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Sclerosing Cholangitis |
Drug: Ursodeoxycholic Acid |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicentered Randomized Trial of High-Dose Urso in Primary Sclerosing Cholangitis |
Estimated Enrollment: | 150 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, Arizona | |
Mayo Clinic | |
Scottsdale, Arizona, United States | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
St. Louis University | |
St. Louis, Missouri, United States | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States | |
United States, Virginia | |
Medical College of Virginia | |
Richmond, Virginia, United States | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States |
Study ID Numbers: | URSO |
Study First Received: | April 21, 2003 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00059202 |
Health Authority: | United States: Federal Government |
Urso PSC |
Primary sclerosing cholangitis Cholangitis Digestive System Diseases Cholangitis, Sclerosing |
Bile Duct Diseases Biliary Tract Diseases Ursodeoxycholic Acid |
Therapeutic Uses Cholagogues and Choleretics Gastrointestinal Agents Pharmacologic Actions |