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 |
---|---|
Conditions: | Back Pain, Chronic Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/-0001 |
Start Date: | June 2012 |
End Date: | June 2013 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
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
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.
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.
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