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Resiniferatoxin for Chronic Pain

Phase 2

Waitlist Available

Research Sponsored by Sorrento Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion at up to approximately 12 months

Awards & highlights

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
Cancer Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion at up to approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion at up to approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion at up to approximately 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the incidence of any treatment-emergent adverse events of epidural Resiniferatoxin (RTX) [safety and tolerability]

Secondary outcome measures

Assess RTX effect on opioid consumption

Assess RTX effect on quality of life

Assess efficacy of RTX on pain associated with advanced cancer

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ResiniferatoxinExperimental Treatment1 Intervention

15 mcg, 20 mcg, or 25 mcg in 2mL injected once into the epidural space

Group II: Concurrent ControlActive Control1 Intervention

No intervention

Group III: PlaceboPlacebo Group1 Intervention

2mL injected once into the epidural space

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resiniferatoxin

2017

Completed Phase 1

~120

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Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor

47 Previous Clinical Trials

1,844 Total Patients Enrolled

Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.

27 Previous Clinical Trials

1,375 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

How many individuals are enrolling in this clinical trial?

"Yes, this trial is looking for enrollees as the information on clinicaltrials.gov 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."

Answered by AI

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."

Answered by AI

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

"That is correct. The information available on clinicaltrials.gov 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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer

2025. "Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067257.