Randomized, multicenter, double blind, placebo controlled trial, for the evaluation of the efficacy and tolerability of ursodeoxycholic acid on the dissolution of cholesterol gallstones (<15mm) after 18 months of therapy

• Conditions: Randomized multicenter double blind, placebo controlled trial, for the evaluation of the efficacy and tolerability of UDCA on the dissolution of cholesterol gallstones (<15mm) after 18 months of therapy.

• Registration Number: EUCTR2005-005919-24-HU
• Lead Sponsor: Dr. Falk Pharma Portugal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1.Patients from both sexes, in ambulatory, with age equal or greater than 18 years old.
2.Biliary lithiasis diagnosed, with radio-lucent cholesterol gallstones <15mm.
3.At least one previous episode of biliary cholic.
4.Functional gallbladder documented by abdominal echography with Boyden Testing.
5.Patient able to follow the study protocol, according to the investigator’s criteria;
6.Informed consent dated and signed by the patient and the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient preference for a surgical treatment
2.Planned surgery within the trial duration period
3.More than half the gallbladder area occupied by gallstones.
4.Presence of non-floating gallstones (bilirubin stones).
5.Presence of stones in the main biliary duct
6.Previous treatment with biliary acids
7.Body Mass Index equal or superior to 35 kg/m2
8.Presence of ascitis
9.Total serum bilirubin >2 mg/ dL
10.Aminotransferases or GGT with values greater than 2.5 times the normal value, for periods lasting longer than 1 month (chronic situation)
11.Impaired kidney function (blood creatinin >2 mg/dL)
12.Patients with heart failure grade III or IV (NYHA)
13.Acute heart infarction in the last year, unstable angina pectoris, de novo angina, Prinzemetal angina or severe bradycardia (according to the investigator’s criteria)
14.Patients with progressive degenerative diseases or life-threatening diseases
15.Patients with life expectancy less than 2 years
16.History of intolerance or allergic reaction to the drug being studied, excipients or analogous drugs.
17.Pregnant or breast-feeding women
18.Women of childbearing potential, not using a contraceptive method of recognized efficacy.
19.History of alcohol abuse or drug addiction
20.Any serious clinical or laboratorial modification that according to the investigator may interfere with the evaluation of efficacy or safety or with any of the study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified