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Completed Phase 3 Interventional Results available

Long Term Safety of Naldemedine

ClinicalTrials.gov ID: NCT01965652

Public ClinicalTrials.gov record NCT01965652. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

Study identification

NCT ID
NCT01965652
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shionogi
Industry
Enrollment
1,246 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 24, 2013 (Actual)
Primary completion
Jan 12, 2016 (Actual)
Completion
Jan 12, 2016 (Actual)
Last update posted
Apr 18, 2018

2013 – 2016

United States locations

U.S. sites
99
U.S. states
31
U.S. cities
99
Facility City State ZIP Site status
Shionogi Research Site Birmingham Alabama — —
Shionogi Research Site Mobile Alabama — —
Shionogi Research Site Chandler Arizona — —
Shionogi Research Site Glendale Arizona — —
Shionogi Research Site Goodyear Arizona — —
Shionogi Research Site Mesa Arizona — —
Shionogi Research Site Phoenix Arizona — —
Shionogi Research Site Tucson Arizona — —
Shionogi Research Site Fountain Valley California — —
Shionogi Research Site Garden Grove California — —
Shionogi Research Site Glendale California — —
Shionogi Research Site Long Beach California — —
Shionogi Research Site Los Angeles California — —
Shionogi Research Site Oceanside California — —
Shionogi Research Site Sacramento California — —
Shionogi Research Site Santa Ana California — —
Shionogi Research Site Upland California — —
Shionogi Research Site Colorado Springs Colorado — —
Shionogi Research Site Boynton Beach Florida — —
Shionogi Research Site Brandon Florida — —
Shionogi Research Site Brooksville Florida — —
Shionogi Research Site Clearwater Florida — —
Shionogi Research Site Fort Myers Florida — —
Shionogi Research Site Jacksonville Florida — —
Shionogi Research Site Lake City Florida — —
Shionogi Research Site Lakeland Florida — —
Shionogi Research Site Orlando Florida — —
Shionogi Research Site South Miami Florida — —
Shionogi Research Site St. Petersburg Florida — —
Shionogi Research Site Tampa Florida — —
Shionogi Research Site Atlanta Georgia — —
Shionogi Research Site Blue Ridge Georgia — —
Shionogi Research Site Decatur Georgia — —
Shionogi Research Site Savannah Georgia — —
Shionogi Research Site Boise Idaho — —
Shionogi Research Site Aurora Illinois — —
Shionogi Research Site Bloomington Illinois — —
Shionogi Research Site Decatur Illinois — —
Shionogi Research Site Rockford Illinois — —
Shionogi Research Site Schaumburg Illinois — —
Shionogi Research Site Evansville Indiana — —
Shionogi Research Site Lafayette Indiana — —
Shionogi Research Site Valparaiso Indiana — —
Shionogi Research Site Augusta Kansas — —
Shionogi Research Site Newton Kansas — —
Shionogi Research Site Wichita Kansas — —
Shionogi Research Site Hartford Kentucky — —
Shionogi Research Site Eunice Louisiana — —
Shionogi Research Site Lake Charles Louisiana — —
Shionogi Research Site Mandeville Louisiana — —
Shionogi Research Site Brockton Massachusetts — —
Shionogi Research Site Fall River Massachusetts — —
Shionogi Research Site New Bedford Massachusetts — —
Shionogi Research Site Rochester Michigan — —
Shionogi Research Site Saginaw Michigan — —
Shionogi Research Site Traverse City Michigan — —
Shionogi Research Site Biloxi Mississippi — —
Shionogi Research Site Fremont Nebraska — —
Shionogi Research Site Omaha Nebraska — —
Shionogi Research Site Henderson Nevada — —
Shionogi Research Site Las Vegas Nevada — —
Shionogi Research Site Trenton New Jersey — —
Shionogi Research Site Albuquerque New Mexico — —
Shionogi Research Site New York New York — —
Shionogi Research Site Greensboro North Carolina — —
Shionogi Research Site Wilmington North Carolina — —
Shionogi Research Site Winston-Salem North Carolina — —
Shionogi Research Site Akron Ohio — —
Shionogi Research Site Canton Ohio — —
Shionogi Research Site Columbus Ohio — —
Shionogi Research Site Groveport Ohio — —
Shionogi Research Site Kettering Ohio — —
Shionogi Research Site Lebanon Ohio — —
Shionogi Research Site Marion Ohio — —
Shionogi Research Site Munroe Falls Ohio — —
Shionogi Research Site Oklahoma City Oklahoma — —
Shionogi Research Site Tulsa Oklahoma — —
Shionogi Research Site Portland Oregon — —
Shionogi Research Site Huntingdon Valley Pennsylvania — —
Shionogi Research Site Jenkintown Pennsylvania — —
Shionogi Research Site Lansdale Pennsylvania — —
Shionogi Research Site Charleston South Carolina — —
Shionogi Research Site Greer South Carolina — —
Shionogi Research Site Myrtle Beach South Carolina — —
Shionogi Research Site Summerville South Carolina — —
Shionogi Research Site Bristol Tennessee — —
Shionogi Research Site Milan Tennessee — —
Shionogi Research Site Nashville Tennessee — —
Shionogi Research Site Austin Texas — —
Shionogi Research Site Dallas Texas — —
Shionogi Research Site Houston Texas — —
Shionogi Research Site Hurst Texas — —
Shionogi Research Site Sugar Land Texas — —
Shionogi Research Site Bountiful Utah — —
Shionogi Research Site Salt Lake City Utah — —
Shionogi Research Site South Ogden Utah — —
Shionogi Research Site Richmond Virginia — —
Shionogi Research Site Bellevue Washington — —
Shionogi Research Site Edmonds Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 87 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01965652, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 18, 2018 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01965652 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →