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Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

NCT01122030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-05-30

Study results available
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Summary

The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

Conditions

  • Opioid Induced Bowel Dysfunction

Interventions

DRUG

Naldemedine

Tablets or solution for oral administration

DRUG

Placebo

Tablets or solution for oral administration

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-05-19
Primary Completion
2011-02-23
Completion
2011-03-22

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 NCT01122030 on ClinicalTrials.gov