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Oral Methylnaltrexone for Opioid-Induced Constipation
NCT01186770Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2010
- Primary completion
- Sep 2011
- Countries
- 1
- Sponsor
- Valeant Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- methylnaltrexone
- Conditions
- opioid-induced constipation (OIC)
01
Overview
Phase 3, randomised, double-blind trial of methylnaltrexone in opioid-induced constipation (OIC) (4 arms), sponsored by Valeant Pharmaceuticals. Primary endpoint: Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing. Started Sep 2010; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
MNTX 150 mg
150 mg QD then PRN
MNTX 300 mg
300 mg QD then PRN
MNTX 450 mg
450 mg QD then PRN
Placebo
Placebo QD then PRN
03
Who it enrols
Adults with chronic non-malignant pain taking opioids for at least 1 month with opioid-induced constipation, willing to discontinue laxatives.
04
Endpoints
Primary
Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing
Secondary
Percentage of Participants Who Responded to Study Drug
Change in Weekly Number of RFBMs From Baseline
05
Results
Primary endpoints met
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