Summary:
A 12 week treatment of an open-label study to assess the efficacy and safety of a Controlled Release Medication 40 to 120 mg taken once-daily in patients with moderate to severe chronic low back pain.
Qualified Participants Must:
• Be on a stable narcotic and be willing to change to our study medication
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Not have had any nerve/plexus block within 4 weeks of the screening visit
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Not have had neuroablation within 6 months of the screening visit
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Not have had a botulinum toxin injection in the low back region within 3 months of the screening visit
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Not have had steroid injections in the lower back within 6 weeks of the screening visit
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Not have had intravenous or intramuscular steroid injections within 4 weeks of the screening visit
Not have a history of seizures
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Not have current uncontrolled depression or other uncontrolled psychiatric disorder
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Not have a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time
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Not have clinically unstable cardiac disease
Not have had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit
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Not have a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
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Not have allergies to other opioids. This does not include patients who have experienced common opioid side effects (eg, nausea, constipation)
Qualified Participants May Receive:
Study medication, lab work, EKGs, hearing tests, and $50.00 for each completed visit for time and travel. Protocol-specific inclusion/exclusion criteria may apply.