Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
805
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
To compare alvimopan with placebo for long-term safety and tolerability
Time frame: 12 months
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
Time frame: 12 months
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GSK Investigational Site
Muscle Shoals, Alabama, United States
GSK Investigational Site
Northport, Alabama, United States
GSK Investigational Site
Glendale, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
...and 217 more locations