NCT06023706

Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.

Detailed description

This trial is a French, multicenter, randomized, controlled, bouble-blind and prospective study. Patients enrolled will be clinically followed for 5 months. The treatment duration per subject is 1 hour (1time).

Conditions

• Coccyx Disorder
• Neuropathic Pain
• Coccygodynia

Interventions

Type	Name	Description
DRUG	Capsaicin 179 Mg Cutaneous Patch	1 patch applied once for 1 hour
DRUG	Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)	1 patch applied once for 1 hour

Timeline

• Start date: 2023-11-08
• Primary completion: 2027-01-08
• Completion: 2027-06-08
• First posted: 2023-09-05
• Last updated: 2026-02-24

Locations

6 sites across 1 country: France