Efficacy and Safety of Naldemedine in the Treatment of 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
Listed as NCT01965158, this PHASE3 trial focuses on Opioid-induced Constipation and remains completed. Sponsored by Shionogi, it has been updated 8 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
8 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 3 earlier versions
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Jul 2017 — Jun 2018 [monthly]
Completed PHASE3
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Feb 2017 — Jul 2017 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Aug 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Shionogi
For direct contact, visit the study record on ClinicalTrials.gov .