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

NCT02578459 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

  • Pain Management
  • Cancer Pain

Interventions

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

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.

Sponsors & Collaborators

  • Flowonix Medical

    lead INDUSTRY

Principal Investigators

  • Daniel R Kloster, MD · Menorah Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-12-31
Completion
2018-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578459 on ClinicalTrials.gov