An interventional study of Intrathecal Drug Delivery System and Conventional Medical Management in Pain Management and Cancer Pain, sponsored by Flowonix Medical. Withdrawn at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Flowonix Medical · Not applicable, Interventional, and Treatment
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.
This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
Browse Pancreatic Neoplasms studies →Flowonix Medical is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
Device: Intrathecal Drug Delivery System
These subjects will be treated with conventional medical management to treat their pain.
Other: Conventional Medical Management
The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
Also known as: Prometra Programmable Infusion System
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.
Visual Analog Scale Pain Scores
Level of pain is rated on the visual analog scale. Pain scores after three months of therapy will be compared to baseline pain scores to see if there is a difference.
Time frame: Three months
Survival Rates
Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type.
Time frame: Two years
Quality of Life Scores
Difference in quality of life between treatment groups.
Time frame: Two years
Cancer Treatments
Difference between treatment group in the number of cancer treatment initiated during the study
Time frame: Two years
Hospitalizations and Emergency Room Visits
Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study
Time frame: Two years
Adverse Events
Adverse events reported by each treatment group will be summarized.
Time frame: Two years
Plan to share: Undecided
This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Flowonix Medical