UDCA for Symptomatic Gallstone Disease

NCT00161083 | Completed Phase 4

• 2 other identifiers: MLDS WS 00-08ZonMw: 920-03-232
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 evaluate potential beneficial effects of impaired gallbladder motility

Conditions

Cholecystolithiasis

Keywords

ursodeoxycholic acid; gallstone; complications; pancreatitis; gallbladder motility; colic

Outcome Measures

Primary Outcomes (1)

• incidence severe right upper quadrant or midline epigastric pain (> 30 min)and colic-free intervals

Secondary Outcomes (1)

• nr gallstone complications (acute cholecystitis, choledocholithiasis or acute pancreatitis) and non-severe right upper quadrant or midline epigastric pain and nr aalgesics taken

Interventions

ursodeoxycholic acid DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Dr. Falk Pharma GmbH: collaborator
• Dutch Digestive Diseases Foundation: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Agis Zorgverzekeringen: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

• Venneman NG, Besselink MG, Keulemans YC, Vanberge-Henegouwen GP, Boermeester MA, Broeders IA, Go PM, van Erpecum KJ. Ursodeoxycholic acid exerts no beneficial effect in patients with symptomatic gallstones awaiting cholecystectomy. Hepatology. 2006 Jun;43(6):1276-83. doi: 10.1002/hep.21182.

  PMID: 16729326 RESULT

MeSH Terms

Conditions

Cholecystolithiasis; Gallstones; Pancreatitis; Colic

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Niels G Venneman, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Karel J van Erpecum, MD, PhD

  UMC Utrecht

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2001
• Study Completion: November 1, 2004
• Last Updated: July 27, 2006

Record last verified: 2005-09

Locations

NL (1)