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Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

NCT00004842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-05-31

No results posted yet for this study

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.

Conditions

  • Cholangitis, Sclerosing
  • Liver Cirrhosis, Biliary

Interventions

DRUG

budesonide

Oral budesonide, 9 mg daily was administered for 1 year

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Keith D. Lindor · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Primary Completion
1999-04-30
Completion
1999-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004842 on ClinicalTrials.gov