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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 Jul 22, 2026, 5:00 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

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

  • Naldemedine Drug
  • Placebo Drug

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 23, 2013
Primary completion
Jan 11, 2016
Completion
Jan 11, 2016
Last update posted
Apr 17, 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 17, 2018 · Synced Jul 22, 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 protocol, eligibility criteria, and contact information for NCT01965652 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →