The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
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
Investigational Site
Alabaster, Alabama, United States
Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Foley, Alabama, United States
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Mobile, Alabama, United States
Investigational Site
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
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Mesa, Arizona, United States
Investigational Site
Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Sun Lakes, Arizona, United States
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Tucson, Arizona, United States
...and 139 more locations