drugset / Trial / NCT00547898

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

NCT00547898

Phase 3 Completed 374 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-10
Primary completion
2011-01-27
Completion
2011-07-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Crofelemer Small molecule 125 mg Oral
Subject Crofelemer Small molecule 250 mg Oral
Subject Crofelemer Small molecule 500 mg Oral

Indications