A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
NCT ID: NCT02578459
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-04-30
2018-09-30
Brief Summary
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Detailed Description
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There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.
A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intrathecal Drug Delivery (ITDD)
These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
Intrathecal Drug Delivery System
The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
Conventional Medical Management (CMM)
These subjects will be treated with conventional medical management to treat their pain.
Conventional Medical Management
Treatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain.
Interventions
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Intrathecal Drug Delivery System
The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
Conventional Medical Management
Treatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
3. Patient agrees not to obtain pain medications from other physicians during the study.
4. Patient is at least 22 years of age.
5. Investigator considers the patient to be able and willing to fulfill all study requirements.
6. Patient is able to understand the study and provide written informed consent to participate in the study.
Exclusion Criteria
2. Patient is enrolled in another clinical study.
22 Years
ALL
No
Sponsors
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Flowonix Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel R Kloster, MD
Role: PRINCIPAL_INVESTIGATOR
Menorah Medical Center
Locations
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Menorah Medical Center
Overland Park, Kansas, United States
Countries
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Related Links
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Dr. Daniel R. Kloster
Other Identifiers
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PM-02
Identifier Type: -
Identifier Source: org_study_id
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