The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain

This study is currently recruiting participants.
Verified February 2014 by The Alfred E. Mann Foundation for Scientific Research
Sponsor:
Information provided by (Responsible Party):
The Alfred E. Mann Foundation for Scientific Research
ClinicalTrials.gov Identifier:
NCT01185470
First received: August 18, 2010
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

• The objectives of this study are to confirm the medication delivery accuracy of the Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine the safety profile of the system with PCA for intrathecal delivery of morphine sulfate for pain control.


Condition Intervention Phase
Cancers
Chronic Pain
Device: Implantation of Morphine Sulfate delivering programmable pump
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: THE CLINICAL EVALUATION OF IMPLANTABLE PUMP SYSTEM FOR SAFETY AND DELIVERY ACCURACY IN PATIENTS REQUIRING INTRATHECAL ADMINISTRATION OF MORPHINE SULFATE FOR CHRONIC PAIN

Resource links provided by NLM:


Further study details as provided by The Alfred E. Mann Foundation for Scientific Research:

Primary Outcome Measures:
  • • Mean medication delivery accuracy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Medication delivery accuracy will be evaluated at each of six (6) refills.


Secondary Outcome Measures:
  • • Tabulation of Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Concomitant Medications, Physical and Neurological Exam, Inflammatory Masses, Vital Signs, Incidence of Inflammatory Masses, Summary of COWS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Tabulation of Concomitant Medications, Tabulation of Physical and Neurological, Exam, Summary of Vital Signs, Incidence of Inflammatory Masses, Summary of COWS


Estimated Enrollment: 75
Study Start Date: February 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects with Implantable pump
Patients with chronic pain responsive to intrathecal opioid analgesia as demonstrated in a morphine trial or patients with a previous successful intrathecal opioid therapy with an implantable pump will undergo study device implantation .
Device: Implantation of Morphine Sulfate delivering programmable pump
Patients with chronic pain responsive to intrathecal opioid analgesia as demonstrated in a morphine trial or patients with a previous successful intrathecal opioid therapy with an implantable pump will undergo implantation of pump for intrathecal delivery of Morphine Sulfate.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be at least 21 years of age.
  2. Subject must have experienced chronic pain for at least 6 months.
  3. Subject must not presently be on intrathecal therapy but must be considered a candidate for intrathecal analgesia by his pain specialist; or, a subject already on intrathecal therapy must be in need of a replacement intrathecal pump and catheter.
  4. Subject must be capable of giving informed consent.
  5. Subjects who agree to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
  6. Subjects who agree to periodic drug testing.
  7. Subject must be capable and willing to follow all study-related procedures, including returning for monthly refills.
  8. Subject must be cognitively intact and, in the opinion of the Investigator, capable of using the Patient Remote.
  9. Subject who is not already successfully treated with intrathecal analgesic therapy must be responsive to a trial of intrathecal or epidural morphine.
  10. Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
  11. Documented failure to respond to less invasive methods of pain control (such as physical or behavioral modifications).
  12. Ineffective pain control with single or multiple systemic analgesic treatments (oral, rectal, IV or transdermal) or had intolerable side effects.
  13. Cancer pain requiring strong opioids or non-malignant pain with average Visual Analog Scale (VAS) score of greater than or equal to 4/10.
  14. Subjects who can receive an MRI.
  15. Subjects must be able to hear and respond to audible alarms or agree to have a support person available who is able to hear and respond to audible alarms.

Exclusion Criteria:

  1. Subject is a female who is pregnant or is planning a pregnancy.
  2. Subject is a nursing mother.
  3. Subject has at the site chosen for implantation a skin condition that would prevent the implantation procedure.
  4. Subject has participated in an investigational drug or device trial within 4 weeks prior to enrollment.
  5. Subject has any known or suspected allergy to morphine or to the materials of the infusion pump or intrathecal catheter.
  6. Subject shows signs of active, systemic infection.
  7. Subject has a known central nervous system contraindication to intrathecal therapy, including but not limited to severe spinal canal stenosis or spinal cord compression.
  8. Subject has a body size that is insufficient to accept the bulk and weight of the pump.
  9. Subject is allergic to morphine sulfate, or for whom morphine sulfate is contraindicated.
  10. Subject has a condition requiring diathermy procedures.
  11. Subject has a life expectancy of less than 9 months.
  12. Subject cannot independently comprehend and participate in the required assessments, including responding to the QOL, BPI, ODI and PGIC measurement tools.
  13. Subject is not considered to be medically or psychologically appropriate for pump implantation.
  14. Subject has a urine drug screen result which indicates the use of prescription drugs or controlled substances not on the order of a physician.
  15. Subjects with an ASA Physical Status >IV.
  16. Subjects with a history of spinal instability, or grade II spondylolisthesis or greater.
  17. Previously implanted subjects with spinal MRI findings of inflammatory mass prior to the implantation procedures.
  18. Subjects who are unable or unwilling to return to all of the required follow-up visits.
  19. Subjects who are unwilling to sign the informed consent.
  20. Subjects who are exposed to high-current industrial equipment (i.e. electricians or electrical engineers) or regularly exposed to MRI equipment (i.e. MRI technicians, MRI engineers and MRI clinicians).
  21. Subjects with active implanted devices such as pacemakers, defibrillators, cochlear implants and neurostimulators or other medical device use that can interfere with the function of the implanted intrathecal pump.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185470

Contacts
Contact: Isabel Arcos, MS 661-702-6729 isabela@aemf.org
Contact: Valma Klein, BS 661-702-6833 valmak@aemf.org

Locations
United States, Arizona
Center for Pain & Supportive Care Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Krisstin Hammond    480-889-0180 ext 205    khammond@azcpsc.com   
Principal Investigator: Lisa Jo Stearns, MD         
United States, California
Coastal Pain Research Recruiting
Carlsbad, California, United States, 92009
Contact: Trisha Mejia, MS    760-607-1736    trisha@coastalpainresearch.com   
Principal Investigator: Michael Sebahar, MD         
University of California San Deigo Recruiting
La Jolla, California, United States, 92093
Contact: Cindy Martin    858-657-7038    L6martin@ucsd.edu   
Principal Investigator: Mark Wallace, M.D.         
Neurovations Recruiting
Napa, California, United States, 94558
Contact: Renee Bell    707-252-9606    reneeb@neurovations.com   
Principal Investigator: Eric Grigsby, M.D.         
United States, Illinois
Millenium Pain Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: Sara Ditchen    309-662-4321    sditchen@millenniumpaincenter.com   
Principal Investigator: Ramsin Benyamin, MD         
United States, Indiana
Global Scientific Innovations, LLC Recruiting
Evansville, Indiana, United States, 47714
Contact: Kiran Kommana    812-437-7719    kiran.kommana@gscin.com   
Principal Investigator: Mahendra Sanapati, MD         
United States, Missouri
Center for Pain Management Recruiting
St. Louis, Missouri, United States, 63109
Contact: Therese Blomberg       therese.blomberg@att.net   
Principal Investigator: Gurpreet Padda, MD         
United States, North Carolina
The Center for Clinical Research Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Jason Hong    336-765-6481 ext 140    jhong@ccrpain.com   
Principal Investigator: Richard Rauck, MD         
United States, Oregon
Pain Research of Oregon Recruiting
Eugene, Oregon, United States, 97401
Contact: Sierra Hovdey, RN    541-684-9451    SHovdey@pain-consultants.com   
Contact: Chris Green    (541) 684-9451    cgreen@pain-consultants.com   
Principal Investigator: Peter Kosek, MD         
Sponsors and Collaborators
The Alfred E. Mann Foundation for Scientific Research
Investigators
Principal Investigator: Richard Rauck, MD The Center for Clinical Research
  More Information

Additional Information:
No publications provided

Responsible Party: The Alfred E. Mann Foundation for Scientific Research
ClinicalTrials.gov Identifier: NCT01185470     History of Changes
Other Study ID Numbers: P100
Study First Received: August 18, 2010
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Alfred E. Mann Foundation for Scientific Research:
Chronic pain
Morphine Sufate
Intrathecal
Implantable drug delivery pumps

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014