High-Dose vs Low-Dose Capsaicin for Neuropathic Pain

Recruiting in Palo Alto (17 mi)

+81 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Averitas Pharma, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is an interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe postsurgical neuropathic pain (PSNP).

Eligibility Criteria

Adults aged 18+ with moderate to severe nerve pain following surgery, who can apply the treatment on intact skin and agree to use birth control if applicable. Excluded are those with confounding conditions like deep tissue pain, planned painful procedures during the trial, or surgeries related to cancer.

Inclusion Criteria

I have had surgery that could cause persistent surgical pain.

I agree to follow the treatment rules and either am not on pain medication for nerve pain or have been on a stable dose for over 30 days.

I have moderate to severe pain, averaging at least 4 out of 10 in the last week.

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Exclusion Criteria

I have severe pain from nerve damage and no planned painful procedures.

I have not had surgery for cancer, chronic pain conditions, or nerve issues.

Treatment Details

Interventions

capsaicin 0.04% topical system (Topical Analgesic)
Qutenza (capsaicin) 8% topical system (Topical Analgesic)

Trial OverviewThe trial is testing Qutenza (8% capsaicin) against a low-dose capsaicin (0.04%) for treating postsurgical neuropathic pain. Participants will be randomly assigned to either group in a double-blind manner, meaning neither they nor the researchers know who gets which treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Qutenza (capsaicin) 8% topical systemExperimental Treatment1 Intervention

Qutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)

Group II: Low-dose capsaicin controlActive Control1 Intervention

capsaicin 0.04% topical system