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Spots Global Cancer Trial Database for NP2 Enkephalin For Treatment of Intractable Cancer Pain

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Trial Identification

Brief Title: NP2 Enkephalin For Treatment of Intractable Cancer Pain

Official Title: A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy

Study ID: NCT01291901

Interventions

NP2
Placebo

Study Description

Brief 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.

Detailed Description: Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

HOPE Research Institute, Phoenix, Arizona, United States

Arizona Clinical Research Center, Tucson, Arizona, United States

Compassionate Cancer Care Medical Group, Inc., Corona, California, United States

Cancer Care Associates, Fresno, California, United States

TriWest Research Associates, La Mesa, California, United States

White Memorial Medical Center, Los Angeles, California, United States

Hematology Oncology Associates, Oakland, California, United States

Advanced Pharma CR, Miami, Florida, United States

Better Health Clinical Research Inc, Newnan, Georgia, United States

Christie Clinic, Champaign, Illinois, United States

Global Scientific Innovations, Evansville, Indiana, United States

Montana Cancer Institute Foundation, Missoula, Montana, United States

Center for Clinical Research, Winston-Salem, North Carolina, United States

Signal Point Clinical research Center, Middletown, Ohio, United States

Pain Research of Oregon, Eugene, Oregon, United States

Hematology Oncology Associatesof Rhode Island, Cranston, Rhode Island, United States

Medical Therapy and Research, San Antonio, Texas, United States

Medical Oncology Associates, Spokane, Washington, United States

Contact Details

Name: Darren Wolfe, Ph.D.

Affiliation: Diamyd Inc

Role: STUDY_DIRECTOR

Name: David Fink, M.D.

Affiliation: University of Michigan

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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