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NP2 Enkephalin For Treatment of Intractable Cancer Pain

NCT01291901 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-08-08

No results posted yet for this study

Summary

The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.

Conditions

  • Intractable Pain
  • Neoplasms

Interventions

BIOLOGICAL

NP2

NP2 is a replication defective HSV-1 based gene transfer vector engineered to express human preproenkephalin. The drug will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.

BIOLOGICAL

Placebo

The placebo (vehicle) will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.

Sponsors & Collaborators

  • Paragon Biomedical

    collaborator INDUSTRY

  • invivodata, Inc.

    collaborator INDUSTRY

  • Diamyd Inc

    lead INDUSTRY

Principal Investigators

  • Darren Wolfe, Ph.D. · Diamyd Inc

  • David Fink, M.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-07-31
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01291901 on ClinicalTrials.gov