The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR). The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Response (Responder/Non-responder) to Study Drug
Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.
Time frame: Baseline to Week 4
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Huntsville, Alabama, United States
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Casa Grande, Arizona, United States
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Gilroy, California, United States
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