Trials / Completed
CompletedNCT01965158
Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 547 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naldemedine | Naldemedine 0.2 mg tablet taken orally once a day |
| DRUG | Placebo | Placebo tablet taken orally once a day |
Timeline
- Start date
- 2013-08-29
- Primary completion
- 2015-01-22
- Completion
- 2015-01-22
- First posted
- 2013-10-18
- Last updated
- 2017-05-30
- Results posted
- 2017-05-30
Locations
65 sites across 7 countries: United States, Austria, Czechia, Germany, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01965158. Inclusion in this directory is not an endorsement.