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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR ACTIGALL


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All Clinical Trials for Actigall

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.
NCT00042549 ↗ Lithotripsy for the Treatment of Gallstones Terminated Medstone International Phase 4 2002-05-01 The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.
NCT00877604 ↗ Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis Completed Federico II University Phase 2 2008-06-01 The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant, antiapoptotic and neuroprotective properties of TUDCA in the central nervous system (CNS), both in vitro and in vivo models. This protocol is meant for assessing if the addition of TUDCA to the conventional therapy can improve the therapeutic outcome in patients affected by ALS. Safety will be assessed for all subjects, for the entire duration of the study. 30 patients affected by ALS with site of onset in the limbs will be recruited. All enrolled subjects will continue receiving riluzole at the same regimen as before entering the trial. Based on an appropriate random code, subjects will be divided into two groups of equal size treated, after a lead-in period of 3 months, by oral route with TUDCA at the dose 2 g daily for 1 year or with identical placebo by oral route at the same dosing schedule, under double-blind conditions. Every concomitant and/or supportive therapy will be admitted. Evaluation criteria: Efficacy. The proportion of responder patients in the two treatment groups was the primary outcome measure of the study. Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R (2) slope during the treatment period as compared to the lead-in period. This threshold was chosen based according to the consensus conference on designing and implementing clinical trials in ALS (3). Other parameters will include ALSFRS-R at study end, FVC%, the SF-36 quality of life rating scale, time to tracheotomy from starting of study medication dosing (if appropriate), survival Time from starting of study medication dosing (if appropriate), Medical Research Council scores for right and left muscle groups. Safety. Incidence, severity and type of adverse events; changes in clinical laboratory findings.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Actigall

Condition Name

Condition Name for Actigall
Intervention Trials
Cholestasis 2
Cystic Fibrosis 1
Esophageal Carcinoma 1
Gastrointestinal Diseases 1
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Condition MeSH

Condition MeSH for Actigall
Intervention Trials
Cholestasis 2
Cholangitis, Sclerosing 1
Cholecystolithiasis 1
Cholangitis 1
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Clinical Trial Locations for Actigall

Trials by Country

Trials by Country for Actigall
Location Trials
United States 16
Italy 1
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Trials by US State

Trials by US State for Actigall
Location Trials
Texas 3
Arizona 2
North Carolina 1
Tennessee 1
Pennsylvania 1
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Clinical Trial Progress for Actigall

Clinical Trial Phase

Clinical Trial Phase for Actigall
Clinical Trial Phase Trials
Phase 4 1
Phase 2 4
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Actigall
Clinical Trial Phase Trials
Completed 3
Terminated 1
Unknown status 1
[disabled in preview] 1
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Clinical Trial Sponsors for Actigall

Sponsor Name

Sponsor Name for Actigall
Sponsor Trials
National Center for Research Resources (NCRR) 1
Phoenix Children's Hospital 1
Medstone International 1
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Sponsor Type

Sponsor Type for Actigall
Sponsor Trials
Other 18
NIH 2
Industry 1
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