Trial Profile

A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 28 Jul 2020

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At a glance

Drugs Lactitol (Primary) ; Lubiprostone
Indications Constipation
Focus Registrational; Therapeutic Use
Sponsors Braintree Laboratories

Most Recent Events

25 Jun 2020 Primary endpoint (Complete Spontaneous Bowel Movement (CSBM)) has been met as per results published in the Clinicaltrials.gov Trial Registry
25 Jun 2020 Results published in the Clinicaltrials.gov Trial Registry
02 Mar 2020 According to a Sebela Pharmaceuticals media release, based on the results of 3 Phase III trials, the U.S. Food and Drug Administration (FDA) has approved Pizensy (lactitol) for oral solution for the once-daily treatment of chronic idiopathic constipation (CIC) in adults.

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