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

April 20, 2017 updated by: Medallion Therapeutics, Inc.

THE CLINICAL EVALUATION OF IMPLANTABLE PUMP SYSTEM FOR SAFETY AND DELIVERY ACCURACY IN PATIENTS REQUIRING INTRATHECAL ADMINISTRATION OF MORPHINE SULFATE FOR CHRONIC PAIN

• 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Center for Pain & Supportive Care
    • California
      • Carlsbad, California, United States, 92009
        • Coastal Pain Research
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Napa, California, United States, 94558
        • Neurovations
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Millenium Pain Center
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Global Scientific Innovations, LLC
    • Missouri
      • Saint Louis, Missouri, United States, 63109
        • Center for Pain Management
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pain Research of Oregon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 ≥ 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
• Mean medication delivery accuracy.
Time Frame: 6 months
Medication delivery accuracy will be evaluated at each of six (6) refills.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
• Tabulation of Adverse Events
Time Frame: 12 months
12 months
Concomitant Medications, Physical and Neurological Exam, Inflammatory Masses, Vital Signs, Incidence of Inflammatory Masses, Summary of COWS
Time Frame: 6 months
Tabulation of Concomitant Medications, Tabulation of Physical and Neurological, Exam, Summary of Vital Signs, Incidence of Inflammatory Masses, Summary of COWS
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medallion Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Rauck, MD, The Center for Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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