High-Dose vs Low-Dose Capsaicin for Neuropathic Pain

Phase 3

Recruiting

Research Sponsored by Averitas Pharma, Inc.

Eligibility Criteria Checklist

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

Must have

The subject has given written informed consent to participate.

Female or male subjects aged 18 years or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the baseline phase (day -7 to day -1) to visit 6 (week 12/day 84).

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new topical pain medication against a low-dose capsaicin control to see if it is more effective and safe in treating moderate to severe post-surgical neuropathic pain.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include local skin reactions such as irritation, redness, burning sensation at the application site; these are more common due to capsaicin's nature of causing a warming or tingling feeling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with chronic moderate to severe nerve pain.

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My skin area for treatment is healthy and smaller than 1120 cm2.

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I have had surgery that could cause persistent surgical pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the baseline phase (day -7 to day -1) to visit 6 (week 12/day 84).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the baseline phase (day -7 to day -1) to visit 6 (week 12/day 84).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the baseline phase (day -7 to day -1) to visit 6 (week 12/day 84). for reporting.