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CLINICAL TRIALS PROFILE FOR URSODIOL
Clinical Trials for Ursodiol
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00004315 | Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease | Unknown status | Children's Hospital Medical Center, Cincinnati | Phase 2 | OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments. |
| NCT00004315 | Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease | Unknown status | National Center for Research Resources (NCRR) | Phase 2 | OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments. |
| NCT00004441 | Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis | Completed | Children's Hospital Medical Center, Cincinnati | N/A | 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. |
| NCT00004748 | Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Completed | Tufts Medical Center | Phase 3 | OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II. Determine the optimum dose and duration of MTX treatment. III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production. |
| NCT00004748 | Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Completed | National Center for Research Resources (NCRR) | Phase 3 | OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II. Determine the optimum dose and duration of MTX treatment. III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production. |
| NCT00004784 | Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 3 | OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity in patients with primary biliary cirrhosis. II. Compare the effects of these regimens on the development of ascites, encephalopathy, varices (or bleeding from pre-existing varices), histologic liver changes, transplantation, and survival. III. Compare the toxicity and safety of each regimen. |
| NCT00004784 | Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis | Completed | University of Texas | Phase 3 | OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity in patients with primary biliary cirrhosis. II. Compare the effects of these regimens on the development of ascites, encephalopathy, varices (or bleeding from pre-existing varices), histologic liver changes, transplantation, and survival. III. Compare the toxicity and safety of each regimen. |
| Trial ID | Title | Status | Sponsor | Phase | Summary |
Clinical Trial Conditions for Ursodiol
Condition Name
Clinical Trial Locations for Ursodiol
Trials by Country
Clinical Trial Progress for Ursodiol
Clinical Trial Phase
Clinical Trial Sponsors for Ursodiol
Sponsor Name
| Sponsor Name for Ursodiol | |
| Sponsor | Trials |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 5 |
| National Cancer Institute (NCI) | 4 |
| National Center for Research Resources (NCRR) | 3 |
| [disabled in preview] | 9 |
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