Renalof in the Treatment of Elderly Patients With Gallstones

Last updated: May 6, 2012
Sponsor: Catalysis SL
Overall Status: Completed

Phase

3

Condition

Liver Disorders

Gall Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT01099319
CAT-1001-CU
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Previous surgical intervention for the treatment of cholelithiasis

  • Cholelithiasis with acute symptoms requiring emergency surgery

  • Cholelithiasis associated with neoplastic condition of any localization or origin

  • Usage of other antioxidants within the duration of the clinical trial

  • Handicap and/or psychiatric condition preventing treatment accomplishment

Study Design

Total Participants: 40
Study Start date:
January 01, 2010
Estimated Completion Date:
June 30, 2011

Connect with a study center

  • "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

    Havana City, Havana
    Cuba

    Site Not Available

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