Resiniferatoxin for Chronic Pain

University of Florida, Gainesville, FL
Chronic Pain+2 More ConditionsResiniferatoxin - Drug
All Sexes

Study Summary

This trial is testing a new pain medication for people with cancer who haven't found relief from other treatments.

Eligible Conditions
  • Chronic Pain
  • Pain
  • Pain, Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline through study completion at up to approximately 12 months

Month 12
Assess RTX effect on opioid consumption
Assess RTX effect on quality of life
Assess efficacy of RTX on pain associated with advanced cancer
Assess the incidence of any treatment-emergent adverse events of epidural Resiniferatoxin (RTX) [safety and tolerability]

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Concurrent Control
1 of 3
1 of 3
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

120 Total Participants · 3 Treatment Groups

Primary Treatment: Resiniferatoxin · Has Placebo Group · Phase 2

Experimental Group · 1 Intervention: Resiniferatoxin · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Concurrent ControlNoIntervention Group · 1 Intervention: Concurrent Control · Intervention Types:
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through study completion at up to approximately 12 months

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,904 Total Patients Enrolled
Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.
27 Previous Clinical Trials
1,435 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have severe pain that hasn't gotten better with usual treatments.
You have pain related to cancer in the lower part of your chest, back or legs.
If you have pain in multiple areas, the pain in the area being studied must be the main source of your pain.

Frequently Asked Questions

Have other patients been studied in this way before?

"There are 4 ongoing clinical trials for Resiniferatoxin in 7 global cities and 1 nation. The original study, which was sponsored by Sorrento Therapeutics, Inc., had 45 patients and completed Phase 1 drug approval in 2009. To date, a total of 18292 trials have been conducted." - Anonymous Online Contributor

Unverified Answer

Could you please tell us if Resiniferatoxin has been researched before?

"Currently, 4 clinical trials are underway to study Resiniferatoxin. Of those active trials, 0 are in Phase 3. Although the majority of research is based out of Pasadena, California - where 11 different medical centres are running trials." - Anonymous Online Contributor

Unverified Answer

How many individuals are enrolling in this clinical trial?

"Yes, this trial is looking for enrollees as the information on indicates. The posting date was November 1st, 2022 with the most recent update happening on October 6th, 2022. They are hoping to find 120 patients total from a single site." - Anonymous Online Contributor

Unverified Answer

What are the dangers that come with Resiniferatoxin use?

"Resiniferatoxin falls into the category of a Phase 2 drug, meaning that while there is some evidence suggesting it is safe, there is none to support its efficacy. Our team at Power estimates its safety to be a 2 on our 3-point scale." - Anonymous Online Contributor

Unverified Answer

Is this a current opportunity for people to enroll in the trial?

"That is correct. The information available on verifies that this particular trial is looking for enrolment from patients. This data was initially posted on November 1st, 2020 and was most recently updated on October 6th, 2020. In total, the study requires 120 participants recruited from a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.