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Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study

NCT02325492 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-10-05

No results posted yet for this study

Summary

This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in their gallbladder following bariatric surgery confirmed by gallbladder ultrasound ..

Conditions

  • Gallstones

Interventions

DRUG

Aramchol

DRUG

Placebo

DEVICE

Ultrasound

Sponsors & Collaborators

  • Galmed Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Asnat Raziel, MD · Assuta Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Israel

Study Locations

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Entities

Drugs

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 NCT02325492 on ClinicalTrials.gov