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Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain

NCT04572776 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-11-09

No results posted yet for this study

Summary

This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.

Conditions

  • Pain, Intractable
  • Pain Cancer

Interventions

DRUG

Resiniferatoxin

Resiniferatoxin is a TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers.

OTHER

Standard of Care

Standard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator.

Sponsors & Collaborators

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Monica Luchi, MD · Sorrento Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572776 on ClinicalTrials.gov