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A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness

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Trial Profile

A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2022

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At a glance

  • Drugs Methylnaltrexone bromide (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Sponsors Bausch Health Companies; Progenics Pharmaceuticals

Most Recent Events

  • 26 Oct 2022 Results of pooled analysis from two studies(n=363, study 302;NCT00402038; study 4000;NCT00672477) investigating if baseline patient characteristics impact the safety and efficacy of Methylnaltrexone for Opioid Induced Constipation in Patients With Advanced Illness presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022
  • 22 Dec 2021 According to Bausch Health Companies media release, data from a post-hoc analysis (study 301, NCT00401362; study 302, NCT00402038; and study 4000, NCT00672477) supports the use of Salix s RELISTOR for patients with Opioid-Induced Constipation and advanced illness in the Emergency Department Setting
  • 22 Dec 2021 Results assessing safety and efficacy of a single methylnaltrexone dose using post hoc polled data from 3 trials (study 301, NCT00401362; study 302, NCT00402038; and study 4000, NCT00672477) published in the Bausch Health Companies Media Release

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