UDCA for Symptomatic Gallstone Disease

NCT00161083 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2006-07-27

No results posted yet for this study

Summary

We conduct a randomized, double-blind, placebo-controlled trial on effects of UDCA on biliary pain and complications in highly symptomatic gallstone patients scheduled for cholecystectomy. We also evaluate potential beneficial effects of impaired gallbladder motility

Conditions

  • Cholecystolithiasis

Interventions

DRUG

ursodeoxycholic acid

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    collaborator INDUSTRY
  • Dutch Digestive Diseases Foundation

    collaborator OTHER
  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER
  • Agis Zorgverzekeringen

    collaborator OTHER
  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Niels G Venneman, MD · UMC Utrecht

  • Karel J van Erpecum, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-11-30
Completion
2004-11-30

Countries

  • Netherlands

Study Locations

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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 NCT00161083 on ClinicalTrials.gov