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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 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 292 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01983306
The ClinicalTrials.gov registry entry for NCT01983306 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01983306 reports 0 study locations.
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.
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