Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
CompletedPhase 2NCT01983306
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Interventions
- Drug: SP-333 1 mg
- Drug: SP-333 3 mg
- Drug: SP-333 6 mg
- Drug: Placebo
- Sponsor
- Bausch Health Americas, Inc.
- Start date
- 2013-11
- Primary completion
- 2014-09
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 42
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening * Must have active OIC at screening * Active OIC must be confirmed during baseline screening bowel habit and symptom diary * Must be on stable diet Exclusion Criteria: * Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction) * Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative) * Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years * Unstable thyroid disease
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01983306