Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
Public ClinicalTrials.gov record NCT01983306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT01983306
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Bausch Health Americas, Inc.
- Industry
- Enrollment
- 292 participants
Conditions and interventions
Conditions
Interventions
- SP-333 1 mg Drug
- SP-333 3 mg Drug
- SP-333 6 mg Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2013
- Primary completion
- Aug 31, 2014
- Completion
- Mar 31, 2015
- Last update posted
- May 6, 2021
2013 – 2015
United States locations
- U.S. sites
- 42
- U.S. states
- 17
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Synergy Research Site | Huntsville | Alabama | 35801 | — |
| Synergy Research Site | Mobile | Alabama | 36608 | — |
| Synergy Research Site | Phoenix | Arizona | 85018 | — |
| Synergy Research Site | Artesia | California | 90701 | — |
| Synergy Research Site | Laguna Hills | California | 92653 | — |
| Synergy Research Site | Oceanside | California | 92056 | — |
| Synergy Research Site | Sacramento | California | 95831 | — |
| Synergy Research Site | San Diego | California | 92103 | — |
| Synergy Research Site | San Diego | California | 92108 | — |
| Synergy Research Site | San Francisco | California | 94103 | — |
| Synergy Research Site | Hialeah | Florida | 33012 | — |
| Synergy Research Site | Miami | Florida | 33173 | — |
| Synergy Research Site | Miami Beach | Florida | 33140 | — |
| Synergy Research Site | Plant City | Florida | 33563 | — |
| Synergy Research Site | Plantation | Florida | 33317 | — |
| Synergy Research Site | Port Orange | Florida | 32129 | — |
| Synergy Research Site | Sarasota | Florida | 34239 | — |
| Synergy Research Site | West Palm Beach | Florida | 33409 | — |
| Synergy Research Site | Winter Haven | Florida | 33880 | — |
| Synergy Research Site | Atlanta | Georgia | 30312 | — |
| Synergy Research Site | Bloomington | Illinois | 61701 | — |
| Synergy Research Site | Traverse City | Michigan | 49684 | — |
| Synergy Research Site | St Louis | Missouri | 63117 | — |
| Synergy Research Site | Las Vegas | Nevada | 89102 | — |
| Synergy Research Site | Great Neck | New York | 11023 | — |
| Synergy Research Site | New York | New York | 10016 | — |
| Synergy Research Site | Concord | North Carolina | 28025 | — |
| Synergy Research Site | Greensboro | North Carolina | 27403 | — |
| Synergy Research Site | Salisbury | North Carolina | 28144 | — |
| Synergy Research Site | Winston-Salem | North Carolina | 27103 | — |
| Synergy Research Site | Dayton | Ohio | 45424 | — |
| Synergy Research Site | Oklahoma City | Oklahoma | 73101 | — |
| Synergy Research Site | Oklahoma City | Oklahoma | 73104 | — |
| Synergy Research Site | Oklahoma City | Oklahoma | 73119 | — |
| Synergy Research Site | Medford | Oregon | 97504 | — |
| Synergy Research Site | Orangeburg | South Carolina | 29118 | — |
| Synergy Research Site | Chattanooga | Tennessee | 37421 | — |
| Synergy Research Site | Arlington | Texas | 76012 | — |
| Synergy Research Site | Dallas | Texas | 75218 | — |
| Synergy Research Site | Dallas | Texas | 75231 | — |
| Synergy Research Site | Houston | Texas | 77081 | — |
| Synergy Research Site | San Antonio | Texas | 78209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01983306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2021 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01983306 live on ClinicalTrials.gov.