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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR URSODIOL

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505(b)(2) Clinical Trials for Ursodiol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00125281 SAMe to Treat Biliary Cirrhosis Symptoms Terminated National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2005-07-01 This study will examine the effect of S-adenosyl methionine (SAMe) on itching and fatigue in patients with primary biliary cirrhosis, a disease of the small bile ducts in the liver. Ursodiol, the only currently available treatment for biliary cirrhosis, does not cure the disease, and many people continue to have symptoms or liver test abnormalities despite treatment. SAMe is a naturally occurring substance found in most cells of the body. The highest levels of the substance are produced by the liver, where it helps to rid the body of toxins and breakdown products of metabolism. Studies in Europe suggest that SAMe may help to: 1) decrease the fatigue and itching that are common in persons with liver problems, and 2) decrease levels of liver enzymes in the blood, suggesting that it may decrease the amount of liver injury. Patients 21 years of age or older with primary biliary cirrhosis who are taking ursodiol and have symptoms of itching or fatigue may be eligible for this study. Candidates are screened with a medical history, physical examination, review of medical records, routine blood tests, and a symptoms rating scale. Participants stop all medications for itching 4 weeks before starting the study, but continue to take ursodiol during the 42-week trial. On entering the study, patients are assigned to take either SAMe or placebo tablets twice a day for 12 weeks. While taking the medications, they are followed in the clinic every 2 weeks for the first month and then every 4 weeks to fill out symptoms questionnaires and have a short medical evaluation and blood tests. At the end of 12 weeks, treatment is interrupted for a 2-week "wash-out" period, after which patients begin a 12-week crossover treatment; that is, patients who were taking SAMe are switched to placebo, and those who were taking placebo are switched to SAMe. After completing the second 12-week treatment course, patients come to the clinic at 4, 8, and 12 weeks to fill out symptoms questionnaires and have a medical evaluation and blood tests. At the last visit, patients are told which type of tablet they received during the two courses of treatment. SAMe is available without prescription in many forms as an over-the-counter medication.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ursodiol

Trial ID Title Status Sponsor Phase Start Date 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 1995-11-01 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 1995-11-01 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 1997-09-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ursodiol

Condition Name

Condition Name for Ursodiol
Intervention Trials
Healthy 5
Liver Cirrhosis, Biliary 4
Colorectal Cancer 2
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Condition MeSH

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

Trials by Country

Trials by Country for Ursodiol
Location Trials
United States 48
Canada 6
Italy 2
Israel 1
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Trials by US State

Trials by US State for Ursodiol
Location Trials
Texas 5
Arizona 3
Washington 3
Pennsylvania 3
California 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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