drugset / Trial / NCT02822508

A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

NCT02822508 ↗

Phase 2/3 Completed 434 enrolled Braintree Laboratories
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.

Timeline

Start
2016-06
Primary completion
2017-04
Completion
2017-04

Outcome

Met primary endpoint

registry analysis (superiority test); BLI801 Laxative (High Dose) vs BLI801 Laxative (Mid Dose) vs BLI801 Laxative (Low Dose) vs BLI801 Placebo; p = 0.034; Cochran-Mantel-Haenszel NCT02822508 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject BLI801 Unknown — Oral

Indications