NCT01924182

Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects

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])

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	SynchroMed Infusion System and Intrathecal Morphine Sulfate	Following a successful test of Intrathecal Morphine Sulfate, subjects will undergo surgery to implant the drug pump (SynchroMed Infusion System) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.
OTHER	Conventional Medicine	Subjects will continue to use pain medications as prescribed by their doctor.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-08-16
• Last updated: 2018-03-29
• Results posted: 2016-03-07

Locations

6 sites across 1 country: United States