At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
budesonidedrug
Likely dose
budesonide 9 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Feb 25, 2000·Updated May 31, 2017
In Brief
A Phase 1 clinical trial evaluating budesonide for Cholangitis, Sclerosing and Liver Cirrhosis, Biliary. Completed, enrolled 22 participants across 1 site.
Detailed Summary
OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholangitis, Sclerosing, Liver Cirrhosis, Biliary
CountriesUnited States
CollaboratorsMayo Clinic
Timeline
Phase 1CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 1997
Primary CompletionApr 1999
First PostedFeb 2000
TodayJul 2026
First PostedFeb 25, 2000
Enrollment StartMay 1, 1997
Primary CompletionApr 1, 1999
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 26.4 years ago
Interventions
budesonidedrug
Oral budesonide, 9 mg daily was administered for 1 year