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Therapeutic Areas: Musculoskeletal | Rheumatology | Family Medicine | Neurology
Disease Category: Chronic Back Pain
Location: United States, GA
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.
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.
Denise Coats, Director of Clinical Research
Georgia Institute for Clinical Research, LLC
335 Roselane Street
Marietta, GA 30060
If you would like to learn more about participating in this study, please send an email message using the form below.
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