Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 10/6/2017 |
Start Date: | November 2013 |
End Date: | April 2015 |
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
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.
doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain
taking opioids.
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
We found this trial at
43
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