NCT03687268

Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase III Trial to Investigate the Efficacy, Safety and Tolerability of Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Develco Pharma Schweiz AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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):

Conditions

• Opioid-Induced Constipation

Interventions

Type	Name	Description
DRUG	Naloxone HCl PR tablets	oral administration
DRUG	Placebo Oral Tablet	Placebo

Timeline

• Start date: 2017-07-31
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2018-09-27
• Last updated: 2018-09-28

Locations

104 sites across 9 countries: Bulgaria, Czechia, Germany, Poland, Portugal, Serbia, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study