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

Completed · Phase 2 · Has a placebo group

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT01983306

Run by

Bausch Health Americas, Inc.

People needed

292

Starts

2013-11-01

Expected to finish

2015-04-01

Last updated by the study team

2021-05-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Synergy Research Site — Huntsville, Alabama, United States
• Synergy Research Site — Mobile, Alabama, United States
• Synergy Research Site — Phoenix, Arizona, United States
• Synergy Research Site — Artesia, California, United States
• Synergy Research Site — Laguna Hills, California, United States
• Synergy Research Site — Oceanside, California, United States
• Synergy Research Site — Sacramento, California, United States
• Synergy Research Site — San Diego, California, United States
• Synergy Research Site — San Diego, California, United States
• Synergy Research Site — San Francisco, California, United States
• Synergy Research Site — Hialeah, Florida, United States
• Synergy Research Site — Miami, Florida, United States
• Synergy Research Site — Miami Beach, Florida, United States
• Synergy Research Site — Plant City, Florida, United States
• Synergy Research Site — Plantation, Florida, United States
• Synergy Research Site — Port Orange, Florida, United States
• Synergy Research Site — Sarasota, Florida, United States
• Synergy Research Site — West Palm Beach, Florida, United States
• Synergy Research Site — Winter Haven, Florida, United States
• Synergy Research Site — Atlanta, Georgia, United States
• Synergy Research Site — Bloomington, Illinois, United States
• Synergy Research Site — Traverse City, Michigan, United States
• Synergy Research Site — St Louis, Missouri, United States
• Synergy Research Site — Las Vegas, Nevada, United States
• Synergy Research Site — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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