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NCT01983306 · ClinicalTrials.gov registry record · Phase 2
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 292
- Enrollment target
NCT01983306: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT01983306 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 292 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01983306, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 292 participants
- Enrollment target
Study 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.
Primary Outcome
Compare SP-333 (1, 3 \& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
Interventions
- DRUG Placebo
- DRUG SP-333 1 mg
- DRUG SP-333 3 mg
- DRUG SP-333 6 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01983306 record still lists
NCT01983306 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (120% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01983306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01983306 about?
NCT01983306 is a clinical study titled "Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)". 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.
What is the current status of trial NCT01983306?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 292 participants. The study started on 2013-11. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01983306?
The interventions under investigation include: Placebo (DRUG), SP-333 1 mg (DRUG), SP-333 3 mg (DRUG), SP-333 6 mg (DRUG).
Who is sponsoring clinical trial NCT01983306?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01983306's enrollment target sits among peer trials
292 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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