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

Phase 2

Completed

Interventions: Drug: SP-333 1 mg
Drug: SP-333 3 mg
Drug: SP-333 6 mg
Drug: Placebo

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SP-333 1 mg	SP-333 1 mg	1 mg SP-333 orally once daily for 4-week Treatment Period
SP-333 3 mg	SP-333 3 mg	3 mg SP-333 orally once daily for 4-week Treatment Period
SP-333 6 mg	SP-333 6 mg	6 mg SP-333 orally once daily for 4-week Treatment Period
Placebo	Placebo	Placebo orally once daily for 4-week Treatment Period

Primary Outcome Measures

Name	Time	Method
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period	4 Weeks	Compare SP-333 (1, 3 \& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period

Secondary Outcome Measures

Name	Time	Method
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC	4 weeks	Compare the safety and tolerability of SP-333 (1, 3 \& 6 mg) with placebo as measured by rates of adverse events, clinical laboratory abnormalities and significant changes in vital signs and ECGs.