The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
439
24 mcg administered orally twice daily (BID)
Matching placebo, 0 mcg administered orally twice daily (BID)
Number of Participants Classified as Treatment Responders Within 12 Weeks
Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
Time frame: 12 weeks
Number of SBMs Per Week at Week 8
Time frame: at Week 8
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation
Time frame: within 48 hours post-dose
Number of SBMs Per Week at Week 12
Time frame: at Week 12
Number of SBMs Per Week Overall
Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.
Time frame: within 14 weeks
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