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

NCT01924182 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-03-29

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • CONVERT TDD Clinical Research Study Team · MedtronicNeuro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924182 on ClinicalTrials.gov