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

NCT01924182 | Terminated Results

• 1 other identifier: 1664 - CONVERT-TDD
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 6

Brief Summary

This study compares two different ways to treat pain. The two ways are:

1. 1.continuing to take current pain medication(s) or
2. 2.receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is implanted.

Conditions

Chronic Pain

Keywords

chronic pain; inadequate pain relief; intolerable side effects

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).

  3 Month

Secondary Outcomes (2)

• Pain Assessment

  3 Month

• Opioid-Related Side Effects

  3 Month

Other Outcomes (1)

• Sleep Assessment

  3 Month

Study Arms (2)

IT group (Intrathecal Morphine Sulfate)

OTHER

SynchroMed Infusion System and Intrathecal Morphine Sulfate

Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate

Conventional Medical Management

OTHER

Conventional Medicine, and then SynchroMed Infusion System and Intrathecal Morphine Sulfate

Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate; Other: Conventional Medicine

Interventions

SynchroMed Infusion System and Intrathecal Morphine Sulfate DEVICE

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.

Also known as: SynchroMed infusion system, Intrathecal morphine sulfate, Infumorph, Targeted drug delivery, Spinal morphine, Intrathecal morphine

Conventional Medical Management; IT group (Intrathecal Morphine Sulfate)

Conventional Medicine OTHER

Subjects will continue to use pain medications as prescribed by their doctor.

Also known as: Standard of Care

Conventional Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (6)

Pain Management Services PC

Homewood, Alabama, 35209, United States

Location

Napa Pain Institute and Neurovations

Napa, California, 94558, United States

Location

IPM Medical Group (Interventional Pain Medical Group)

Walnut Creek, California, 94598, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

University of Virginia Pain Management Center

Charlottesville, Virginia, 22908-0710, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Due to the small sample size (only 1 IT Group and 0 CMM Group participants completed the primary outcome assessment), statistical tests cannot be performed and conclusions cannot be made on any of the original study objectives.

Results Point of Contact

• Title: Mary Markert Sr Prin Clinical Research Specialist
• Organization: Medtronic Neuromodulation

mary.a.markert@medtronic.com

763-526-8162

Study Officials

• CONVERT TDD Clinical Research Study Team

  MedtronicNeuro

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 29, 2018
• Results First Posted: March 7, 2016

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)