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A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

NCT01443403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2017-06-26

Study results available
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Summary

The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.

Conditions

  • Opioid-induced Constipation

Interventions

DRUG

Placebo

Matching placebo tablets administered orally once a day.

DRUG

Naldemedine

Naldemedine tablets administered 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-17
Primary Completion
2012-08-22
Completion
2012-08-22

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 NCT01443403 on ClinicalTrials.gov