CancersPhase 2/3NCT01185470
The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain
A Phase 2/3 study testing Implantation of Morphine Sulfate delivering programmable pump in people with Cancers and Chronic Pain, run by Medallion Therapeutics, Inc. at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancers, Chronic Pain
- What is being tested?
- Implantation of Morphine Sulfate delivering programmable pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2011to Jul 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subjects with a history of spinal instability, or grade II spondylolisthesis or greater.
- Previously implanted subjects with spinal MRI findings of inflammatory mass prior to the implantation procedures.
- Subjects who are unable or unwilling to return to all of the required follow-up visits.
- Subjects who are unwilling to sign the informed consent.
- 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).
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Millenium Pain Center
Bloomington, Illinois, 61701
Coastal Pain Research
Carlsbad, California, 92009
Pain Research of Oregon
Eugene, Oregon, 97401
Global Scientific Innovations, LLC
Evansville, Indiana, 47714
University of California San Diego
La Jolla, California, 92093
Neurovations
Napa, California, 94558
Center for Pain & Supportive Care
Scottsdale, Arizona, 85258
Center for Pain Management
St Louis, Missouri, 63109
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
- 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.
- Conditions
- Cancers, Chronic Pain
- Being tested
- Implantation of Morphine Sulfate delivering programmable pump
- Keywords
- Chronic pain, Morphine Sufate, Intrathecal, Implantable drug delivery pumps
- Medical subject headings
- Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: Implantation of Morphine Sulfate delivering programmable pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Mean medication delivery accuracy.
Medication delivery accuracy will be evaluated at each of six (6) refills.
Measured: 6 months
Secondary outcomes (2)
• Tabulation of Adverse Events
Measured: 12 months
Concomitant Medications, Physical and Neurological Exam, Inflammatory Masses, Vital Signs, Incidence of Inflammatory Masses, Summary of COWS
Tabulation of Concomitant Medications, Tabulation of Physical and Neurological, Exam, Summary of Vital Signs, Incidence of Inflammatory Masses, Summary of COWS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startFeb 2011
- Primary completionJan 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medallion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Rauck, MD, Principal investigator, The Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185470
- Sponsor's protocol ID
- P100
- Status last verified
- Apr 2017
- First submitted
- 18 Aug 2010
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01185470
- Acronym / sponsor ID
- P100
- Conditions
- Cancers, Chronic Pain
- Keywords
- Chronic pain, Morphine Sufate, Intrathecal, Implantable drug delivery pumps
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medallion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Implantable pump | Experimental | Device: Implantation of Morphine Sulfate delivering programmable pumpPatients 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 . |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of Morphine Sulfate delivering programmable pumpPatients 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. | Device | Subjects with Implantable pump |
Primary outcome
• Mean medication delivery accuracy.
Time frame: 6 months
Medication delivery accuracy will be evaluated at each of six (6) refills.
2 secondary outcomes
• Tabulation of Adverse Events
Time frame: 12 months
Concomitant Medications, Physical and Neurological Exam, Inflammatory Masses, Vital Signs, Incidence of Inflammatory Masses, Summary of COWS
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Rauck, MD principal investigator
The Center for Clinical Research
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Implantation of Morphine Sulfate delivering programmable pump in people with Cancers and Chronic Pain, run by Medallion Therapeutics, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Mean medication delivery accuracy. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.