Trial intelligence / Profile preview

Naloxone HCl prolonged-release tablets for opioid-induced constipation

2012-004311-31Phase 3Completed

Sponsor
Develco Pharma
Start
Jan 2013
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Countries
1
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Overview

Phase 3, randomised, double-blind trial in opioid-induced constipation (OIC) and opioid-induced bowel dysfunction (OIBD) comparing Naloxone hydrochloride prolonged-release tablets with Placebo (2 arms). Primary endpoint: Absolute change in Bowel Function Index score at Week 12. Started Jan 2013; status: completed.

02

Drugs

naloxone
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Conditions

opioid-induced constipation (OIC)opioid-induced bowel dysfunction (OIBD)

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