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Brief Title: Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Official Title: A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Study ID: NCT05067257
Brief Summary: This Phase 2 study assesses the safety and efficacy of a single injection of Resiniferatoxin versus placebo for the treatment of intractable advanced cancer pain.
Detailed Description: This is a global multicenter, randomized Phase 2 study for subjects with advanced cancer experiencing intractable pain to assess the safety and efficacy of a single epidural injection of Resiniferatoxin versus vehicle control. Additional subjects who elect to not enroll but are willing to be followed will comprise a Concurrent Control Group. Subjects will be followed for twelve months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Altman Clinical and Translational Research Institute (ACTRI), La Jolla, California, United States
University of Florida, Gainesville, Florida, United States
Oregon Health & Science University, Portland, Oregon, United States
HD Research, Bellaire, Texas, United States
Name: Mike Royal, MD
Affiliation: Sorrento Therapeutics, Inc.
Role: STUDY_DIRECTOR