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Renalof in the Treatment of Elderly Patients With Gallstones

NCT01099319 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-05-08

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Renalof

One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.

DIETARY_SUPPLEMENT

Placebo

One Placebo tablet (Orally administered) every 8 hours, for 6 months

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Guillermo Hernández Mojena, MD · "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Cuba

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099319 on ClinicalTrials.gov