Completed PHASE3 INTERVENTIONAL 2-arm NCT01993940

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Sponsor: Shionogi

Conditions Opioid-induced Constipation

Interventions Naldemedine Placebo

Updated 7 times since 2017 Last updated: Apr 19, 2017 Started: Nov 4, 2013 Primary completion: Jun 9, 2015 Completion: Jun 9, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01993940, this PHASE3 trial focuses on Opioid-induced Constipation and remains completed. Sponsored by Shionogi, it has been updated 7 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jul 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jul 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Nov 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Shionogi

Data source: Shionogi Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Anaheim, United States , Birmingham, United States , Buena Park, United States , Butte, United States , Channelview, United States , Chesapeake, United States , Chester, United States , Clarksburg, United States , Columbus, United States and 38 more locations