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 (Naxos)

NCT03687268 Phase 3 UNKNOWN

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):

Details

Lead sponsor	Develco Pharma Schweiz AG
Phase	Phase 3
Status	UNKNOWN
Enrolment	1500
Start date	2017-07-31
Completion	2019-12

Conditions

• Opioid-Induced Constipation

Interventions

• Naloxone HCl PR tablets
• Placebo Oral Tablet

Primary outcomes

• Proportion of overall CSBM Responders. — 12 weeks
  Overall CSBM response defined as ≥ 3 CSBMs/week and an increase of ≥ 1 CSBM/week compared to baseline during at least 9 out of the 12 treatment weeks, including all of the last 4 weeks.

Countries

Bulgaria, Czechia, Germany, Poland, Portugal, Serbia, Slovakia, Spain, United Kingdom