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CLINICAL TRIALS PROFILE FOR URSODIOL

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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.

Clinical Trial Conditions for Ursodiol

Condition Name

Condition Name for Ursodiol
Intervention	Trials
Healthy	5
Liver Cirrhosis, Biliary	4
Cystic Fibrosis	2

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Condition MeSH

Condition MeSH for Ursodiol
Intervention	Trials
Fibrosis	8
Liver Cirrhosis, Biliary	6
Liver Cirrhosis	6

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Clinical Trial Locations for Ursodiol

Trials by Country

Trials by Country for Ursodiol
Location	Trials
United States	47
Canada	6
Italy	2
Israel	1

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Trials by US State

Trials by US State for Ursodiol
Location	Trials
Texas	4
Washington	3
Pennsylvania	3
California	3
Ohio	3

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Clinical Trial Progress for Ursodiol

Clinical Trial Phase

Clinical Trial Phase for Ursodiol
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 2/Phase 3	2

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Clinical Trial Status

Clinical Trial Status for Ursodiol
Clinical Trial Phase	Trials
Completed	17
Recruiting	4
Terminated	4

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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

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Sponsor Type

Sponsor Type for Ursodiol
Sponsor	Trials
Other	39
NIH	13
Industry	8

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