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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Pain, Low Back Pain, Analgesia

In brief

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.

Key facts

Study ID

NCT01571362

Run by

Pfizer

People needed

410

Starts

2012-06-01

Expected to finish

2013-06-01

Last updated by the study team

2017-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dedicated Clinical Research — Goodyear, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Premier Research Group Limited — Phoenix, Arizona, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Med Center — Carmichael, California, United States
• Med Investigations, Inc. — Fair Oaks, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Pacific Coast Pain Management Center — Laguna Hills, California, United States
• Long Beach Center for Clinical Research - previous addresse — Long Beach, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Clinicos, LLC — Colorado Springs, Colorado, United States
• Lynn Institute of the Rockies Medical Centre — Colorado Springs, Colorado, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Ormond Medical Arts pharmaceutical Research Center — Ormond Beach, Florida, United States
• Gold Coast Research, LLC — Plantation, Florida, United States
• The Office of Martin E. Hale, MD, PA — Plantation, Florida, United States
• Accord Clinical Research, LLC- Duplicate 2 — Port Orange, Florida, United States
• Accord Clinical Research, LLC- Duplicate — Port Orange, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Drug Studies America — Marietta, Georgia, United States
• Georgia Institute for Clinical Research, LLC — Marietta, Georgia, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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