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

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ClinicalTrials.gov Identifier: NCT01924182
Recruitment Status : Terminated (Amendment changes were significant enough to warrant a new study.)
First Posted : August 16, 2013
Results First Posted : March 7, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Pain Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate Other: Conventional Medicine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
IT group (Intrathecal Morphine Sulfate)
SynchroMed Infusion System and Intrathecal Morphine Sulfate
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 Names:
  • SynchroMed infusion system
  • Intrathecal morphine sulfate
  • Infumorph
  • Targeted drug delivery
  • Spinal morphine
  • Intrathecal morphine

Conventional Medical Management
Conventional Medicine, and then SynchroMed Infusion System and Intrathecal Morphine Sulfate
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 Names:
  • SynchroMed infusion system
  • Intrathecal morphine sulfate
  • Infumorph
  • Targeted drug delivery
  • Spinal morphine
  • Intrathecal morphine

Other: Conventional Medicine
Subjects will continue to use pain medications as prescribed by their doctor.
Other Name: Standard of Care




Primary Outcome Measures :
  1. Clinical Success [ Time Frame: 3 Month ]
    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 :
  1. Pain Assessment [ Time Frame: 3 Month ]
    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).

  2. Opioid-Related Side Effects [ Time Frame: 3 Month ]
    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).


Other Outcome Measures:
  1. Sleep Assessment [ Time Frame: 3 Month ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924182


Locations
United States, Alabama
Pain Management Services PC
Homewood, Alabama, United States, 35209
United States, California
Napa Pain Institute and Neurovations
Napa, California, United States, 94558
IPM Medical Group (Interventional Pain Medical Group)
Walnut Creek, California, United States, 94598
United States, Florida
Compass Research
Orlando, Florida, United States, 32806
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Virginia
University of Virginia Pain Management Center
Charlottesville, Virginia, United States, 22908-0710
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Director: CONVERT TDD Clinical Research Study Team MedtronicNeuro

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01924182     History of Changes
Other Study ID Numbers: 1664 - CONVERT-TDD
First Posted: August 16, 2013    Key Record Dates
Results First Posted: March 7, 2016
Last Update Posted: March 29, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MedtronicNeuro:
chronic pain
inadequate pain relief
intolerable side effects

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents