Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

Summary

Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily. The trial will consist of four phases: Screening phase (Week -4 to Week -3): Confirmation phase (Week -2 to Week -1): Double-blind treatment phase Follow-up phase (Week 13-14):

Timeline

Start

2017-07-31

Primary completion

2019-11

Completion

2019-12

Drugs

Indications