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Therapeutic Areas: Musculoskeletal | Rheumatology | Family Medicine | Neurology
Disease Category: Chronic Back Pain
Location: United States, GA

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

Patient 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 opioids and non-opioid analgesics during the study.

Patient Exclusion Criteria:

  • Active or history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as cancer, infection, spinal stenosis or post-surgical intervention.
  • Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfer with assessment of chronic low back pain.
  • Active or ongoing or history of alcohol or drug abuse.

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Duration

12 Weeks

Facility Type

N/A

Contact

Denise Coats, Director of Clinical Research
Georgia Institute for Clinical Research, LLC
335 Roselane Street
Marietta, GA 30060
Phone: 770-420-4658

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Research Center Information: Georgia Institute for Clinical Research, LLC

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 182384

Date Last Changed: July 18, 2013


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