A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Naltrexone; Oxycodone

Criteria

Inclusion Criteria:

• Moderate-to-severe chronic low back pain present for at least 3 months.

• Require a continuous around-the-clock opioid analgesic for an extended period of time.

• Refrain from taking other opioid and non-opioid medications during the study.

Exclusion Criteria:

• Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention.

• Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.

• Active or ongoing or history of alcohol or drug abuse.