CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 374 enrolled
Drug / intervention
Crofelemer 125 mg +3 moredrug
Likely dose
Crofelemer 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00547898
NCT00547898Phase 3Completed
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Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of 3 Doses of Crofelemer Orally Twice Daily for the Treatment of HIV-Associated Diarrhea

Bausch Health Americas, Inc.·interventional·Posted Oct 23, 2007·Updated Sep 3, 2020

In Brief

A Phase 3 clinical trial evaluating Crofelemer 125 mg, Crofelemer 250 mg, and 2 other interventions for HIV Associated Diarrhea. Completed, enrolled 374 participants across 82 sites in 2 countries.

Detailed Summary

This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Associated Diarrhea
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 23, 2007
Enrollment StartOct 1, 2007
Primary CompletionJan 27, 2011
Study CompletionJul 11, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.7 years ago

Interventions

Crofelemer 125 mgdrug

Crofelemer 125 mg

Crofelemer 250 mgdrug

Crofelemer 250 mg

Crofelemer 500 mgdrug

Crofelemer 500 mg

Placebodrug

Placebo