NCT01185470

Brief Summary

• 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

August 18, 2010

Last Update Submit

April 20, 2017

Conditions

CancersChronic Pain

Keywords

Chronic painMorphine SufateIntrathecalImplantable drug delivery pumps

Outcome Measures

Primary Outcomes (1)

  • • Mean medication delivery accuracy.

    Medication delivery accuracy will be evaluated at each of six (6) refills.

    6 months

Secondary Outcomes (2)

  • • Tabulation of Adverse Events

    12 months

  • Concomitant Medications, Physical and Neurological Exam, Inflammatory Masses, Vital Signs, Incidence of Inflammatory Masses, Summary of COWS

    6 months

Study Arms (1)

Subjects with Implantable pump

EXPERIMENTAL

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

Interventions

Implantation of Morphine Sulfate delivering programmable pumpDEVICE

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.

Subjects with Implantable pump

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be at least 21 years of age.
  • Subject must have experienced chronic pain for at least 6 months.
  • 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.
  • Subject must be capable of giving informed consent.
  • Subjects who agree to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study physician.
  • Subjects who agree to periodic drug testing.
  • Subject must be capable and willing to follow all study-related procedures, including returning for monthly refills.
  • Subject must be cognitively intact and, in the opinion of the Investigator, capable of using the Patient Remote.
  • Subject who is not already successfully treated with intrathecal analgesic therapy must be responsive to a trial of intrathecal or epidural morphine.
  • Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
  • Documented failure to respond to less invasive methods of pain control (such as physical or behavioral modifications).
  • Ineffective pain control with single or multiple systemic analgesic treatments (oral, rectal, IV or transdermal) or had intolerable side effects.
  • Cancer pain requiring strong opioids or non-malignant pain with average Visual Analog Scale (VAS) score of ≥ 4/10.
  • Subjects who can receive an MRI.
  • 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.

You may not qualify if:

  • Subject is a female who is pregnant or is planning a pregnancy.
  • Subject is a nursing mother.
  • Subject has at the site chosen for implantation a skin condition that would prevent the implantation procedure.
  • Subject has participated in an investigational drug or device trial within 4 weeks prior to enrollment.
  • Subject has any known or suspected allergy to morphine or to the materials of the infusion pump or intrathecal catheter.
  • Subject shows signs of active, systemic infection.
  • Subject has a known central nervous system contraindication to intrathecal therapy, including but not limited to severe spinal canal stenosis or spinal cord compression.
  • Subject has a body size that is insufficient to accept the bulk and weight of the pump.
  • Subject is allergic to morphine sulfate, or for whom morphine sulfate is contraindicated.
  • Subject has a condition requiring diathermy procedures.
  • Subject has a life expectancy of less than 9 months.
  • Subject cannot independently comprehend and participate in the required assessments, including responding to the QOL, BPI, ODI and PGIC measurement tools.
  • Subject is not considered to be medically or psychologically appropriate for pump implantation.
  • Subject has a urine drug screen result which indicates the use of prescription drugs or controlled substances not on the order of a physician.
  • Subjects with an ASA Physical Status \>IV.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Center for Pain & Supportive Care

Scottsdale, Arizona, 85258, United States

Location

Coastal Pain Research

Carlsbad, California, 92009, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Neurovations

Napa, California, 94558, United States

Location

Millenium Pain Center

Bloomington, Illinois, 61701, United States

Location

Global Scientific Innovations, LLC

Evansville, Indiana, 47714, United States

Location

Center for Pain Management

St Louis, Missouri, 63109, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Pain Research of Oregon

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

NeoplasmsChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Rauck, MD

    The Center for Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 20, 2010

Study Start

February 1, 2011

Primary Completion

January 1, 2015

Study Completion

July 1, 2016

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

US(9)