Trials / Completed
CompletedNCT01443403
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 244 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Matching placebo tablets administered orally once a day. |
| DRUG | Naldemedine | Naldemedine tablets administered orally once a day. |
Timeline
- Start date
- 2011-08-17
- Primary completion
- 2012-08-22
- Completion
- 2012-08-22
- First posted
- 2011-09-29
- Last updated
- 2017-06-26
- Results posted
- 2017-05-30
Locations
49 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01443403. Inclusion in this directory is not an endorsement.