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Completed Phase 2 Interventional

Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)

ClinicalTrials.gov ID: NCT01983306

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.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 9:04 PM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

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

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
Nov 2013 (Type not available)
Primary completion
Sep 2014 (Actual)
Completion
Apr 2015 (Actual)
Last update posted
May 7, 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 7, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01983306 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →