A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
Public ClinicalTrials.gov record NCT01443403. 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 S-297995 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 determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
Study identification
- NCT ID
- NCT01443403
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 244 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 17, 2011 (Actual)
- Primary completion
- Aug 22, 2012 (Actual)
- Completion
- Aug 22, 2012 (Actual)
- Last update posted
- Jun 26, 2017
2011 – 2012
United States locations
- U.S. sites
- 49
- U.S. states
- 24
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shionogi Research Site | Phoenix | Arizona | — | — |
| Shionogi Research Site | Sun Lakes | Arizona | — | — |
| Shionogi Research Site | Little Rock | Arkansas | — | — |
| Shionogi Research Site | Anaheim | California | — | — |
| Shionogi Research Site | Fresno | California | — | — |
| Shionogi Research Site | Lincoln | California | — | — |
| Shionogi Research Site | Lomita | California | — | — |
| Shionogi Research Site | Denver | Colorado | — | — |
| Shionogi Research Site | Brandon | Florida | — | — |
| Shionogi Research Site | Kissimmee | Florida | — | — |
| Shionogi Research Site | New Port Richey | Florida | — | — |
| Shionogi Research Site | North Miami | Florida | — | — |
| Shionogi Research Site | Ocala | Florida | — | — |
| Shionogi Research Site | Orlando | Florida | — | — |
| Shionogi Research Site | Ormond Beach | Florida | — | — |
| Shionogi Research Site | Port Orange | Florida | — | — |
| Shionogi Research Site | Sarasota | Florida | — | — |
| Shionogi Research Site | South Miami | Florida | — | — |
| Shionogi Research Site | West Palm Beach | Florida | — | — |
| Shionogi Research Site | Atlanta | Georgia | — | — |
| Shionogi Research Site | Decatur | Georgia | — | — |
| Shionogi Research Site | Marietta | Georgia | — | — |
| Shionogi Research Site | Evansville | Indiana | — | — |
| Shionogi Research Site | Lexington | Kentucky | — | — |
| Shionogi Research Site | Shreveport | Louisiana | — | — |
| Shionogi Research Site | Owings Mills | Maryland | — | — |
| Shionogi Research Site | Watertown | Massachusetts | — | — |
| Shionogi Research Site | Worcester | Massachusetts | — | — |
| Shionogi Research Site | Traverse City | Michigan | — | — |
| Shionogi Research Site | Edina | Minnesota | — | — |
| Shionogi Research Site | Las Vegas | Nevada | — | — |
| Shionogi Research Site | Newington | New Hampshire | — | — |
| Shionogi Research Site | Berlin | New Jersey | — | — |
| Shionogi Research Site | Willingboro | New Jersey | — | — |
| Shionogi Research Site | Hartsdale | New York | — | — |
| Shionogi Research Site | North Syracuse | New York | — | — |
| Shionogi Research Site | Williamsville | New York | — | — |
| Shionogi Research Site | Wilmington | North Carolina | — | — |
| Shionogi Research Site | Winston-Salem | North Carolina | — | — |
| Shionogi Research Site | Canton | Ohio | — | — |
| Shionogi Research Site | Columbus | Ohio | — | — |
| Shionogi Research Site | Perrysburg | Ohio | — | — |
| Shionogi Research Site | Eugene | Oregon | — | — |
| Shionogi Research Site | Philadelphia | Pennsylvania | — | — |
| Shionogi Research Site | Greer | South Carolina | — | — |
| Shionogi Research Site | Austin | Texas | — | — |
| Shionogi Research Site | Dallas | Texas | — | — |
| Shionogi Research Site | Orem | Utah | — | — |
| Shionogi Research Site | Salt Lake City | Utah | — | — |
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 NCT01443403, 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 Jun 26, 2017 · Synced Oct 24, 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 NCT01443403 live on ClinicalTrials.gov.