Conditions: Opioid-Induced Constipation
Keywords: Cancer-Related Pain Opioid-Induced Constipation OIC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Oral treatment arm 2: Oral treatment arm 3: Oral treatment

Interventions: intervention 1: NKTR-118 intervention 2: NKTR-118 intervention 3: Placebo
Intervention descriptions: intervention 1: 12.5 mg oral tablet once daily intervention 2: 25 mg oral tablet once daily intervention 3: Oral treatment

Protocol document: