At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, And Parallel-Group Study Of Subcutaneous Methylnaltrexone (MOA-728) For The Treatment Of Opioid-Induced Constipation In Adult Subjects
In Brief
A Phase 3 clinical trial evaluating Methylnaltrexone and Placebo for Constipation. Completed, enrolled 50 participants across 6 sites in 2 countries.
Detailed Summary
The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.
Study Details
Timeline
Interventions
Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and \< 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and \<38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).
Subjects received matching placebo injections. Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments).