MedTrace Logo

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

NCT01993940 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 553

Last updated 2017-05-30

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

Conditions

  • Opioid-induced Constipation

Interventions

DRUG

Naldemedine

Naldemedine 0.2 mg tablet taken orally once a day

DRUG

Placebo

Placebo tablet taken orally once a day

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-04
Primary Completion
2015-06-09
Completion
2015-06-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01993940 on ClinicalTrials.gov