Trials / Completed
CompletedNCT01965652
Long Term Safety of Naldemedine
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,246 (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 long-term safety of naldemedine for the treatment of constipation due to opioid therapy.
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
- 2013-09-24
- Primary completion
- 2016-01-12
- Completion
- 2016-01-12
- First posted
- 2013-10-18
- Last updated
- 2018-04-18
- Results posted
- 2017-05-30
Locations
186 sites across 16 countries: United States, Australia, Austria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, South Africa, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01965652. Inclusion in this directory is not an endorsement.