Status:
COMPLETED
UDCA for Symptomatic Gallstone Disease
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Dr. Falk Pharma GmbH
Dutch Digestive Diseases Foundation
Conditions:
Cholecystolithiasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 eva...
Detailed Description
Gallstone disease is very common with an estimated prevalence of 10-15% in the adult Western population. Approximately 90% of gallstone carriers are asymptomatic. The annual risk of biliary colic in a...
Eligibility Criteria
Inclusion
- Patients between 18 and 75 years of age study are upon admission to the waiting list for elective cholecystectomy for symptomatic cholecystolithiasis defined as:
- presence of gallbladder stones or sludge, without bile duct stones or bile duct dilatation at ultrasonography;\\
- at least one episode of severe right upper quadrant or midline epigastric pain of at least 30 min. duration, with radiation and/or movement urge, or at least three episodes of severe right upper quadrant or midline epigastric pain of at least 30 min. duration without such radiation or movement urge, in the previous 12 months
Exclusion
- Contra-indication for general anaesthesia or surgery
- Current or previous acute cholecystitis, obstructive jaundice or pancreatitis
- Previous papillotomy, because of preferential flow of UDCA-enriched bile to the intestine rather than to the gallbladder
- Pregnancy or lactation
- Current or previous use of UDCA
- Participation in another study
- Inability to speak Dutch or English or mental disability
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00161083
Start Date
November 1 2001
End Date
November 1 2004
Last Update
July 27 2006
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands, 3508 GA