The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
455
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
Placebo tablets to match OXN or OXY taken orally every 12 hours
Overall complete spontaneous bowel movement (CSBM) responder rates
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
Time frame: Weeks 1 through 12
CSBM Responder at least 50% of the weeks in the double-blind period
Time frame: Weeks 1 through 12
Laxative-free Responder at least 50% of the weeks in the double-blind period
Time frame: Weeks 1 through 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site
Alabaster, Alabama, United States
Investigational Site
Birmingham, Alabama, United States
Investigational Site
Gulf Shores, Alabama, United States
Investigational Site
Homewood, Alabama, United States
Investigational Site
Huntsville, Alabama, United States
Investigational Site
Mobile, Alabama, United States
Investigational Site
Goodyear, Arizona, United States
Investigational Site
Goodyear, Arizona, United States
Investigational Site
Phoenix, Arizona, United States
Investigational Site
Phoenix, Arizona, United States
...and 184 more locations