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])

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.

Inclusion Criteria:

• Signed and dated Medtronic/IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed
• Willing and able to attend visits and comply with the study protocol
• Willing and able to abstain from alcohol consumption for the study duration
• At least 18 years of age
• Male or non-pregnant, non-lactating female
• Currently receiving </= 300 mg/day morphine equivalent of systemic opioids at screening
• Used a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the Screening as documented in the medical history
• Used chronic systemic opioids for at least 6 months prior to Screening as documented in medical history

Per investigator's medical assessment and the subject's medical history, the subject is/has:

• A new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy)
• A diagnosis of nonmalignant, chronic intractable pain as documented in the medical history
• Medically stable and able to undergo surgery for implantation of the SynchroMed Infusion System
• Completed a psychological evaluation within 6 months prior to Screening

Exclusion Criteria:

• Psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion
• A history of alcohol abuse or any illicit drug use within 2 years prior to Screening
• A positive urine test for illicit drugs at Screening (Exception: If subject has a physician's prescription for an illicit drug; for example, medical marijuana)
• Known diagnosis of moderate to severe sleep apnea.
• Prescribed Continuous Positive Airway Pressure (CPAP), Adaptive Servo-Ventilation (ASV) therapy or an oral appliance prescribed for the treatment of moderate to severe sleep apnea (current or previous history)
• An active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
• An implanted electrical stimulation device(s) or if the subject is expected to require one of these during the course of the study
• Planned to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening

Prior to Randomization, a subject will be excluded if:

• Diary does not meet compliance
• Mean diary-reported 12-hour NPRS < 6 (on 0 to 10 scale, as reported over 5 days)
• Positive urine test for alcohol at Baseline
• Negative urine test for opioids at Baseline
• Baseline sleep study (PSG) with SaO2 <=80% for >= 5 consecutive minutes, and/or an Apnea-Hypopnea Index (AHI) >=15.