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

Primary Purpose

Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SynchroMed Infusion System and Intrathecal Morphine Sulfate
Conventional Medicine
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, inadequate pain relief, intolerable side effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pain Management Services PC
  • Napa Pain Institute and Neurovations
  • IPM Medical Group (Interventional Pain Medical Group)
  • Compass Research
  • The Center for Clinical Research
  • University of Virginia Pain Management Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

IT group (Intrathecal Morphine Sulfate)

Conventional Medical Management

Arm Description

SynchroMed Infusion System and Intrathecal Morphine Sulfate

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain Assessment
Compare changes from Baseline to Month 3 between the IT group and CMM group in Numeric Pain Rating Scale (NPRS). The scale measures pain intensity. Using NPRS, a pain score ranging from 0 (no pain) to 10 (pain as bad as you can imagine) is recorded on a subject diary twice daily for 5 days before a study visit. The score for each visit is calculated as the mean pain of the 5 diary days morning and evening scores. For each subject, the change in pain will be calculated as the mean pain score at Month 3 minus the mean pain score at Baseline. A negative change value represents a lowering of the pain score (an improvement, or reduction in pain).
Opioid-Related Side Effects
Summarize the changes from Baseline to Month 3 between the IT group and CMM group in Common Terminology Criteria for Adverse Events (CTCAE) toxicity score. (from the National Cancer Institute) A subset of 23 specific items of the CTCAE v4.03 were evaluated. The subset was chosen as these criteria were most related to opioid side effects that are of interest in this study. The investigator scored the assessment at each visit. The total score for a visit is based on the sum of 23 individual CTCAE's. The individual scales have a range of 0 to 2, 0 to 3, or 0 to 5 and the total score ranges from 0 (best case) to 90 (worst case). For each subject, the change in toxicity will be calculated as the total toxicity score at Month 3 minus the total toxicity score at Baseline. A negative change value represents a lowering of the subjects toxicity score (an improvement, or reduction in toxicity).

Full Information

First Posted
August 13, 2013
Last Updated
February 28, 2018
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT01924182
Brief Title
Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects
Acronym
CONVERT-TDD
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])
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Amendment changes were significant enough to warrant a new study.
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares two different ways to treat pain. The two ways are: continuing to take current pain medication(s) or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, inadequate pain relief, intolerable side effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IT group (Intrathecal Morphine Sulfate)
Arm Type
Other
Arm Description
SynchroMed Infusion System and Intrathecal Morphine Sulfate
Arm Title
Conventional Medical Management
Arm Type
Other
Arm Description
Conventional Medicine, and then SynchroMed Infusion System and Intrathecal Morphine Sulfate
Intervention Type
Device
Intervention Name(s)
SynchroMed Infusion System and Intrathecal Morphine Sulfate
Other Intervention Name(s)
SynchroMed infusion system, Intrathecal morphine sulfate, Infumorph, Targeted drug delivery, Spinal morphine, Intrathecal morphine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Medicine
Other Intervention Name(s)
Standard of Care
Intervention Description
Subjects will continue to use pain medications as prescribed by their doctor.
Primary Outcome Measure Information:
Title
Clinical Success
Description
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).
Time Frame
3 Month
Secondary Outcome Measure Information:
Title
Pain Assessment
Description
Compare changes from Baseline to Month 3 between the IT group and CMM group in Numeric Pain Rating Scale (NPRS). The scale measures pain intensity. Using NPRS, a pain score ranging from 0 (no pain) to 10 (pain as bad as you can imagine) is recorded on a subject diary twice daily for 5 days before a study visit. The score for each visit is calculated as the mean pain of the 5 diary days morning and evening scores. For each subject, the change in pain will be calculated as the mean pain score at Month 3 minus the mean pain score at Baseline. A negative change value represents a lowering of the pain score (an improvement, or reduction in pain).
Time Frame
3 Month
Title
Opioid-Related Side Effects
Description
Summarize the changes from Baseline to Month 3 between the IT group and CMM group in Common Terminology Criteria for Adverse Events (CTCAE) toxicity score. (from the National Cancer Institute) A subset of 23 specific items of the CTCAE v4.03 were evaluated. The subset was chosen as these criteria were most related to opioid side effects that are of interest in this study. The investigator scored the assessment at each visit. The total score for a visit is based on the sum of 23 individual CTCAE's. The individual scales have a range of 0 to 2, 0 to 3, or 0 to 5 and the total score ranges from 0 (best case) to 90 (worst case). For each subject, the change in toxicity will be calculated as the total toxicity score at Month 3 minus the total toxicity score at Baseline. A negative change value represents a lowering of the subjects toxicity score (an improvement, or reduction in toxicity).
Time Frame
3 Month
Other Pre-specified Outcome Measures:
Title
Sleep Assessment
Description
Compare changes from Baseline to Month 3 between the IT group and CMM group for Apnea-Hypopnea Index (AHI). The AHI was collected via overnight sleep lab polysomnography. The AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI values for adults are categorized as Normal: AHI<5, Mild sleep apnea: 5≤AHI<15, Moderate sleep apnea: 15≤AHI<30, Severe sleep apnea: AHI≥30. For each subject, the change in AHI will be calculated as the AHI at Month 3 minus the AHI at Baseline. A negative change value represents a lowering of the subjects AHI (an improvement, or reduction in sleep apnea).
Time Frame
3 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CONVERT TDD Clinical Research Study Team
Organizational Affiliation
MedtronicNeuro
Official's Role
Study Director
Facility Information:
Facility Name
Pain Management Services PC
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Napa Pain Institute and Neurovations
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
IPM Medical Group (Interventional Pain Medical Group)
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Virginia Pain Management Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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