Chronic Pain Clinical Trial
Official title:
Post-market Study Evaluating a Treatment Conversion to Low Dose Intrathecal Morphine From Conventional Medical Management for Maintenance of Pain Control and Improvement of Opioid-related Side Effects. (CONVERT Targeted Drug Delivery [TDD])
This study compares two different ways to treat pain. The two ways are:
1. continuing to take current pain medication(s) or
2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your
body) that is implanted.
None of the procedures or products used in this study are experimental. The length the study
will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare
pain and opioid side effects between people who get a drug pump and people who do not get a
drug pump that will stay on their current pain medication treatment.
This was a randomized, controlled, open-label, multi-center, prospective post-market study to assess pain control and opioid-related side effects following a route of delivery change to low dose IT morphine therapy from systemic opioid therapy. Subjects with nonmalignant, chronic, intractable pain who were experiencing inadequate pain relief and/or intolerable side effects from systemic opioid therapy receiving ≤300 mg/day morphine equivalent dose were eligible for screening. Additionally, the subjects had no known history of sleep apnea and were candidates for IT morphine administration via the SynchroMed Infusion System. Subjects must not have previously undergone an intrathecal/epidural trial for pump infusion therapy. ;
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