The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
157
Alkermes Study Site
Mesa, Arizona, United States
Alkermes Study Site
Phoenix, Arizona, United States
Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response.
Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response.
Time frame: 4 weeks
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Alkermes Study Site
National City, California, United States
Alkermes Study Site
Oceanside, California, United States
Alkermes Study Site
Pasadena, California, United States
Alkermes Study Site
Denver, Colorado, United States
Alkermes Investigational Site
DeLand, Florida, United States
Alkermes Study Site
Ormond Beach, Florida, United States
Alkermes Study Site
St. Petersburg, Florida, United States
Alkermes Study Site
Stockbridge, Georgia, United States
...and 10 more locations