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
•
Not have had any nerve/plexus block within 4 weeks of the screening visit, neuroablation within 6 months of the screening visit, a botulinum toxin injection in the low back region within 3 months of the screening visit, steroid injections in the lower back within 6 weeks of the screening visit, or intravenous or intramuscular steroid injections within 4 weeks of the screening visit
•No history of seizures
•No current uncontrolled depression or other uncontrolled psychiatric disorder
•No history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time
•Not have clinically unstable cardiac disease
•No surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit
•No history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
•No 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.