Clinical Trial: Renalof in the Treatment of Elderly Patients With Gallstones
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones
Brief Summary: The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.
Detailed Summary:
Sponsor: Catalysis SL
Current Primary Outcome:
- Size of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment) [ Time Frame: 6 month ]
- Number of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment) [ Time Frame: 6 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Presence of digestive symptoms associated with cholelithiasis [ Time Frame: 6 month ]
- Occurrence of adverse effects during treatment [ Time Frame: 6 month ]
Original Secondary Outcome: Same as current
Information By: Catalysis SL
Dates:
Date Received: April 5, 2010
Date Started: January 2010
Date Completion:
Last Updated: May 6, 2012
Last Verified: May 2012
