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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Darren Wolfe, Ph.D.
Affiliation: Diamyd Inc
Role: STUDY_DIRECTOR
Name: David Fink, M.D.
Affiliation: University of Michigan
Role: PRINCIPAL_INVESTIGATOR