Long Term Safety of Naldemedine
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.
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
Conditions
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.