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Completed Phase 3 Interventional Results available

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

ClinicalTrials.gov ID: NCT01993940

Public ClinicalTrials.gov record NCT01993940. 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 22, 2026, 8:22 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 Study of Naldemedine in 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 efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

Study identification

NCT ID
NCT01993940
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shionogi
Industry
Enrollment
553 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
Nov 4, 2013 (Actual)
Primary completion
Jun 9, 2015 (Actual)
Completion
Jun 9, 2015 (Actual)
Last update posted
May 30, 2017

2013 – 2015

United States locations

U.S. sites
49
U.S. states
25
U.S. cities
49
Facility City State ZIP Site status
Shionogi Research Site Birmingham Alabama — —
Shionogi Research Site Homewood Alabama — —
Shionogi Research Site Goodyear Arizona — —
Shionogi Research Site Little Rock Arkansas — —
Shionogi Research Site Anaheim California — —
Shionogi Research Site Buena Park California — —
Shionogi Research Site Corona California — —
Shionogi Research Site Gold River California — —
Shionogi Research Site Los Angeles California — —
Shionogi Research Site Modesto California — —
Shionogi Research Site Pasadena California — —
Shionogi Research Site Coral Gables Florida — —
Shionogi Research Site Hialeah Florida — —
Shionogi Research Site Jacksonville Florida — —
Shionogi Research Site Miami Florida — —
Shionogi Research Site Miami Beach Florida — —
Shionogi Research Site Plantation Florida — —
Shionogi Research Site Columbus Georgia — —
Shionogi Research Site Evansville Indiana — —
Shionogi Research Site Indianapolis Indiana — —
Shionogi Research Site West Des Moines Iowa — —
Shionogi Research Site Edgewood Kentucky — —
Shionogi Research Site Crowley Louisiana — —
Shionogi Research Site Kalamazoo Michigan — —
Shionogi Research Site Traverse City Michigan — —
Shionogi Research Site Butte Montana — —
Shionogi Research Site Omaha Nebraska — —
Shionogi Research Site Las Vegas Nevada — —
Shionogi Research Site Omaha Nevada — —
Shionogi Research Site Albuquerque New Mexico — —
Shionogi Research Site Hopewell Junction New York — —
Shionogi Research Site Mooresville North Carolina — —
Shionogi Research Site Winston-Salem North Carolina — —
Shionogi Research Site Dayton Ohio — —
Shionogi Research Site Marion Ohio — —
Shionogi Research Site Media Pennsylvania — —
Shionogi Research Site Spartanburg South Carolina — —
Shionogi Research Site Knoxville Tennessee — —
Shionogi Research Site Tullahoma Tennessee — —
Shionogi Research Site Channelview Texas — —
Shionogi Research Site Fort Worth Texas — —
Shionogi Research Site Groesbeck Texas — —
Shionogi Research Site Houston Texas — —
Shionogi Research Site Plano Texas — —
Shionogi Research Site San Antonio Texas — —
Shionogi Research Site Chesapeake Virginia — —
Shionogi Research Site Chester Virginia — —
Shionogi Research Site Tacoma Washington — —
Shionogi Research Site Clarksburg West Virginia — —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01993940, 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 May 30, 2017 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01993940 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →