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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
292
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
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
Time frame: 4 Weeks
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
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.
Time frame: 4 weeks
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