A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

February 13, 2019 updated by: Flowonix Medical
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient has Stage IV pancreatic cancer.
  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:

  1. Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
  2. Patient is enrolled in another clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrathecal Drug Delivery (ITDD)
These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
Device: 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.
Other Names:
  • Prometra Programmable Infusion System
Active Comparator: Conventional Medical Management (CMM)
These subjects will be treated with conventional medical management to treat their pain.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale Pain Scores
Time Frame: Three months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rates
Time Frame: Two years
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
Time Frame: Two years
Difference in quality of life between treatment groups.
Two years
Cancer Treatments
Time Frame: Two years
Difference between treatment group in the number of cancer treatment initiated during the study
Two years
Hospitalizations and Emergency Room Visits
Time Frame: Two years
Difference between treatment group in the number of times they are hospitalized or visit the emergency room during the study
Two years
Adverse Events
Time Frame: Two years
Adverse events reported by each treatment group will be summarized.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flowonix Medical

Investigators

  • Principal Investigator: Daniel R Kloster, MD, Menorah Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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