Trial Information

A Multicenter, 12-Week, Double-blind, Placebo-controlled, Randomized, Withdrawal Study to Determine the Efficacy and Safety of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-release Capsules in Subjects with Moderate to Severe Chronic Low Back Pain

Patient Inclusion Criteria:

Male or female 18 years of age or older that has moderate to severe, unspecific, chronic low back pain requiring opioid treatment. Average chronic low back pain of 5-9 on a 0-10 pain scale.

Patient Exclusion Criteria:

Patients with: radiculopathy, cancer, underlying back infection, spinal stenosis, osteoarthritis, rheumatoid arthritis, fibromyalgia, neuropathic pain syndromes, migraine, recent trauma, infection, ongoing alcohol or drug abuse, severe acute or chronic medical or physchiatric consitions, suicide attempts within the last year or suicidal ideation, pregnant or breastfeeding females, hypersensitivity to oxycodone, naltrexone, or acetaminophen, back surgery in the last 6 months, epidural steroid injections in the last 3 months, elective surgery in the last 2 months, involved in active back pain litigation, resolved back pain litigation or receiving disability payments pertaining to a back pain injury.

Nicole Baney RN, Research Coordinator
Allegheny Pain Management
1402 Ninth Avenue
Altoona, PA 16602
Phone: 814-940-2000 ext 603
Email: nbaney@alleghenypainmanagement.com

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Research Center Information: Allegheny Pain Management

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