Trial record 14 of 2885 for:    Open Studies | "Pain"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01924182
First received: August 13, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Nonmalignant Pain
Chronic Pain
Chronic Intractable Pain
Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-market, Randomized, Controlled, Prospective Study Evaluating a Treatment Conversion to Low Dose Intrathecal Morphine (IT) From Conventional Medical Management (CMM) for Maintenance of Pain Control and Improvement of Opioid-related Side Effects. (CONVERT Targeted Drug Delivery [TDD])

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: 3 Month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 Month ] [ Designated as safety issue: No ]
    Compare changes from Baseline to Month 3 between the IT group and CMM group in NPRS

  • Opioid-Related Side Effects [ Time Frame: 3 Month ] [ Designated as safety issue: Yes ]
    Summarize the changes from Baseline to Month 3 between the IT group and CMM group in CTCAE


Other Outcome Measures:
  • Sleep Assessment [ Time Frame: 3 Month ] [ Designated as safety issue: Yes ]

    Compare changes from Baseline to Month 3 between the IT group and CMM group for:

    Sleep and respiratory parameters collected via overnight polysomnography (PSG, sleep study)



Estimated Enrollment: 222
Study Start Date: October 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IT Group (SynchroMed/Intrathecal Morphine Sulfate)
Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.
Device: SynchroMed Infusion System and Intrathecal Morphine Sulfate
Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.
Other Names:
  • Implanted drug pump
  • Intrathecal pain medication
  • Infumorph
  • Targeted drug delivery
  • Spinal morphine
  • Intrathecal morphine
No Intervention: Conventional Medical Management
Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924182

Contacts
Contact: CONVERT TDD Clinical Research Study Team medtronicneurotrials@medtronic.com

Locations
United States, California
Napa Pain Institute and Neurovations Recruiting
Napa, California, United States, 94558
Contact: Renee Bell    707-252-9606    reneeb@neurovations.com   
Contact       info@neurovations.com   
Principal Investigator: Eric Grigsby, M.D.         
IPM Medical Group (Interventional Pain Medical Group) Recruiting
Walnut Creek, California, United States, 94598
Contact: Kat Abtahi, BS    925-478-5488    2kattya@gmail.com   
Contact: Jonathan Briz    925-478-5488    jbrizipm@gmail.com   
Principal Investigator: Kasra Amirdelfan, M.D.         
United States, Florida
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact: Millie Lopez    407-210-1300    mlopez@compassresearch.com   
Principal Investigator: Michael Creamer, M.D.         
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Samantha Wheeler    336-714-8388 ext 153    swheeler@ccrpain.com   
Contact: Whitney Thompson    336-714-8388 ext 120    wthompson@ccrpain.com   
Principal Investigator: Richard Rauck, M.D.         
United States, Virginia
University of Virginia Pain Management Center Recruiting
Charlottesville, Virginia, United States, 22908-0710
Contact: Robert Goldstein, M.D.    434-924-2283    rbg7a@hscmail.mcc.virginia.edu   
Contact: Lucas Fernandez    434-249-7636    lgf5k@virginia.edu   
Principal Investigator: Robert Goldstein, M.D.         
Sponsors and Collaborators
MedtronicNeuro
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01924182     History of Changes
Other Study ID Numbers: 1664
Study First Received: August 13, 2013
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014