Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
Public ClinicalTrials.gov record NCT01965158. 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.
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
- NCT01965158
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 547 participants
Conditions and interventions
Conditions
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
- Aug 29, 2013 (Actual)
- Primary completion
- Jan 22, 2015 (Actual)
- Completion
- Jan 22, 2015 (Actual)
- Last update posted
- May 30, 2017
2013 – 2015
United States locations
- U.S. sites
- 37
- U.S. states
- 20
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shionogi Research Site | Birmingham | Alabama | — | — |
| Shionogi Research Site | Phoenix | Arizona | — | — |
| Shionogi Research Site | Fresno | California | — | — |
| Shionogi Research Site | Long Beach | California | — | — |
| Shionogi Research Site | National City | California | — | — |
| Shionogi Research Site | North Hollywood | California | — | — |
| Shionogi Research Site | Oceanside | California | — | — |
| Shionogi Research Site | Golden | Colorado | — | — |
| Shionogi Research Site | Miami | Florida | — | — |
| Shionogi Research Site | Miami Springs | Florida | — | — |
| Shionogi Research Site | Orlando | Florida | — | — |
| Shionogi Research Site | Sarasota | Florida | — | — |
| Shionogi Research Site | West Palm Beach | Florida | — | — |
| Shionogi Research Site | Winter Park | Florida | — | — |
| Shionogi Research Site | Marietta | Georgia | — | — |
| Shionogi Research Site | Shreveport | Louisiana | — | — |
| Shionogi Research Site | Caro | Michigan | — | — |
| Shionogi Research Site | Flint | Michigan | — | — |
| Shionogi Research Site | Hazelwood | Missouri | — | — |
| Shionogi Research Site | Las Vegas | Nevada | — | — |
| Shionogi Research Site | Belvidere | New Jersey | — | — |
| Shionogi Research Site | East Brunswick | New Jersey | — | — |
| Shionogi Research Site | Albuquerque | New Mexico | — | — |
| Shionogi Research Site | Great Neck | New York | — | — |
| Shionogi Research Site | Hollis | New York | — | — |
| Shionogi Research Site | New Windsor | New York | — | — |
| Shionogi Research Site | Winston-Salem | North Carolina | — | — |
| Shionogi Research Site | Cincinnati | Ohio | — | — |
| Shionogi Research Site | Oklahoma City | Oklahoma | — | — |
| Shionogi Research Site | Medford | Oregon | — | — |
| Shionogi Research Site | West Reading | Pennsylvania | — | — |
| Shionogi Research Site | Chattanooga | Tennessee | — | — |
| Shionogi Research Site | Arlington | Texas | — | — |
| Shionogi Research Site | Austin | Texas | — | — |
| Shionogi Research Site | Dallas | Texas | — | — |
| Shionogi Research Site | Houston | Texas | — | — |
| Shionogi Research Site | San Antonio | Texas | — | — |
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 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01965158, 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 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 NCT01965158 live on ClinicalTrials.gov.