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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Children's Hospital Medical Center, Cincinnati |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004441 |
OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease. II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and fat-soluble vitamin status in these patients.
Condition | Intervention |
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Cystic Fibrosis |
Drug: tauroursodeoxycholic acid Drug: ursodiol |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Estimated Enrollment: | 39 |
Study Start Date: | September 1997 |
PROTOCOL OUTLINE: Objective I: This part of the study is a dose-response study to determine the optimal dose of tauroursodeoxycholic acid (TUDCA).
Twenty-four patients are randomized to receive one of three different doses of TUDCA for 3 months.
Objective II: This part of the study is a double-blind crossover study to compare optimized doses of TUDCA with optimized doses of ursodiol in 15 patients stratified according to age (less than 10 vs 10-20 vs more than 20 years). Patients are randomized to receive either TUDCA or ursodiol orally for an initial 3 month period, followed by a 3 month washout period in which no drug is administered. Patients then receive the alternate drug for 3 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
United States, Colorado | |
Children's Hospital of Denver | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Michael Narkowicz 303-861-6669 | |
United States, Ohio | |
Children's Hospital Medical Center - Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Kenneth Setchell 513-636-4548 | |
Italy | |
University of Milan | Recruiting |
Milan, Italy, 20122 | |
Contact: Carla Colombo 2-8-912-9975 |
Study Chair: | Kenneth Setchell | Children's Hospital Medical Center, Cincinnati |
Study ID Numbers: | 199/13439, CHMC-C-001439, CHMC-C-96-1-8, CHMC-C-FDR001439-01 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004441 History of Changes |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease |
Taurochenodeoxycholic Acid Fibrosis Respiration Disorders Tauroursodeoxycholic acid Rare Diseases Antiviral Agents Ursodeoxycholic Acid |
Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases |
Anti-Infective Agents Taurochenodeoxycholic Acid Fibrosis Tauroursodeoxycholic acid Gastrointestinal Agents Antiviral Agents Pharmacologic Actions Digestive System Diseases Pathologic Processes |
Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Therapeutic Uses Lung Diseases Cholagogues and Choleretics Pancreatic Diseases Infant, Newborn, Diseases |