Study Stopped
The study was never initiated by sponsor. Patients where never recruited.
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedFebruary 15, 2019
July 1, 2018
8 months
October 14, 2015
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Survival Rates
Two years
Quality of Life Scores
Two years
Cancer Treatments
Two years
Hospitalizations and Emergency Room Visits
Two years
Adverse Events
Two years
Study Arms (2)
Intrathecal Drug Delivery (ITDD)
EXPERIMENTALThese subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
Conventional Medical Management (CMM)
ACTIVE COMPARATORThese subjects will be treated with conventional medical management to treat their pain.
Interventions
The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
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.
Eligibility Criteria
You may qualify if:
- Patient has Stage IV pancreatic cancer.
- Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
- Patient agrees not to obtain pain medications from other physicians during the study.
- Patient is at least 22 years of age.
- Investigator considers the patient to be able and willing to fulfill all study requirements.
- Patient is able to understand the study and provide written informed consent to participate in the study.
You may not qualify if:
- Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
- Patient is enrolled in another clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flowonix Medicallead
Study Sites (1)
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel R Kloster, MD
Menorah Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2015
First Posted
October 19, 2015
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
September 1, 2018
Last Updated
February 15, 2019
Record last verified: 2018-07