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Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

NCT03687268 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2018-09-28

No results posted yet for this study

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

DRUG

Naloxone HCl PR tablets

oral administration

DRUG

Placebo Oral Tablet

Placebo

Sponsors & Collaborators

  • Develco Pharma Schweiz AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2019-11-30
Completion
2019-12-31
FDA Drug
Yes

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687268 on ClinicalTrials.gov