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The study was never initiated by sponsor. Patients where never recruited.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Drug Delivery (ITDD) | Experimental | These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. |
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| Conventional Medical Management (CMM) | Active Comparator | These subjects will be treated with conventional medical management to treat their pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Drug Delivery System | Device | The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rates | Data will be analyzed to test for correlation between survival and pain scores, and survival rates and treatment type. | Two years |
| Quality of Life Scores | Difference in quality of life between treatment groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel R Kloster, MD | Menorah Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
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| Label | URL |
|---|---|
| Dr. Daniel R. Kloster | View source |
| Dr. Jaswinder Singh | View source |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D000072716 | Cancer Pain |
| D010146 | Pain |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Conventional Medical Management | Other | 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. |
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| Two years |
| Cancer Treatments | Difference between treatment group in the number of cancer treatment initiated during the study | 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 | Two years |
| Adverse Events | Adverse events reported by each treatment group will be summarized. | Two years |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |