NP2 Enkephalin For Treatment of Intractable Cancer Pain

Neoplasms Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Intractable Pain
• Neoplasms
• Pain, Intractable

• NCT number: NCT01291901
• Study type: Interventional
• Source: Diamyd Inc
• Status: Completed
• Phase: Phase 2
• Start date: January 2011
• Completion date: November 2013