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

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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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Alliance, Nebraska 69301
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Akron, Ohio 44314
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Alabaster, Alabama 35007
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Albuquerque, New Mexico 87108
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Anderson, South Carolina 29621
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Arvada, Colorado 80005
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Asheville, North Carolina 28801
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Atlanta, Georgia 30309
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Avon, Indiana 46123
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Baltimore, Maryland 21234
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Boston, Massachusetts 02115
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Cape Girardeau, Missouri 63703
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Cranston, Rhode Island 02920
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Gilbert, Arizona 85234
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Houston, Texas 77030
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Incline Village, Nevada 89451
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Los Angeles, California 90027
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Norman, Oklahoma 73069
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Pittsburgh, Pennsylvania 15212
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Rochester, New York 14642
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