drugset / Trial / NCT01983306

Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)

NCT01983306 ↗

Phase 2 Completed 292 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.

Timeline

Start
2013-11
Primary completion
2014-09
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolcanatide Protein / enzyme biologic 1 mg Oral
Subject Dolcanatide Protein / enzyme biologic 3 mg Oral
Subject Dolcanatide Protein / enzyme biologic 6 mg Oral

Indications