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.
Conditions
Interventions
Trade Name: ORSOFALK 250 mg kapszula
Product Name: Ursofalk
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Dr. Falk Pharma Portugal
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of UDCA efficacy (versus placebo) after 18 months of therapy, in the complete dissolution of radio-lucent cholesterol gallstones with <15mm of greater diameter, occupying less than half the gallbladder area.;Secondary Objective: Evaluation of the incidence of biliary colic episodes, hospitalization and surgery due to acute cholecystitis or acute episode of chronical cholecystitis, biliary lithiasis, choledocho-lithiasis or biliary pancreatitis, in each group Evaluation of maintenance of response (complete stone dissolution) after a 6-month open trial period without therapy. Evaluation of UDCA treatment safety and tolerability, versus placebo. ;Primary end point(s): Complete dissolution of gallstones, incidence of biliary colic, hospitalization and surgery due to acute cholecystitis or acute episode of chronical cholecystitis, biliary lithiasis, choledocho-lithiasis or biliary pancreatitis, in each group. Maintenance of complete stone dissolution after a 6-month open trial period without therapy. Evaluation of UDCA treatment safety and tolerability, versus placebo. | — |
Countries
Hungary
Outcome results
None listed