Trials / Completed
CompletedNCT01983306
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 292 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SP-333 1 mg | Tablet |
| DRUG | SP-333 3 mg | Tablet |
| DRUG | SP-333 6 mg | Tablet |
| DRUG | Placebo | Tablet |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2014-09-01
- Completion
- 2015-04-01
- First posted
- 2013-11-13
- Last updated
- 2021-05-07
Locations
42 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01983306. Inclusion in this directory is not an endorsement.