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

NCT06023706 | Recruiting Phase 3

• 1 other identifier: RC22_0415
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Coccyx Disorder; Neuropathic Pain; Coccygodynia

Outcome Measures

Primary Outcomes (1)

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

  The difference in the proportion of subjects improved (PGIC≤2) in either treatment group at day 60. It is expected that there will be a difference of at least 20% between treatment arms.

  Day 60

Secondary Outcomes (9)

• Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days

  time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and through study completion (an average of 5 months)

• Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study.

  Throughout the study (an average of 5 months)

• Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study.

  Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.

• Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).

  Over 5 months

• Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).

  Over 5 months

Study Arms (2)

Capsaicin 179 mg cutaneous patch

EXPERIMENTAL

Capsaicin 179 mg cutaneous patch. 1 patch applied once for 1 hour at inclusion visit.

Drug: Capsaicin 179 Mg Cutaneous Patch

Capsaicin low concentration patch

PLACEBO COMPARATOR

Capsaicin 0.04 cutaneous patch. 1 patch applied once for 1 hour at inclusion visit

Drug: Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)

Interventions

Capsaicin 179 Mg Cutaneous Patch DRUG

1 patch applied once for 1 hour

Also known as: qutenza

Capsaicin 179 mg cutaneous patch

Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2) DRUG

1 patch applied once for 1 hour

Capsaicin low concentration patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting with chronic coccygodynia: pain in the coccygeal region, increased by sitting and or when rising from a sitting position and pain over the last ten days of intensity greater than or equal to four on the eleven-point numerical scale (from zero to ten) and having been present for more than 3 months.
• Failure of previous treatments: NSAIDs, pressure-relieving cushions and/or infiltration or having a contraindication to these treatments, or not wishing to receive these treatments
• Have never been treated with an 8% capsaicin patch for this indication
• With at least one clinical sign suggestive of neuropathic pain (burning, painful cold, numbness, tingling, electric discharge, allodynia of the gluteal groove, allodynia to pressure on the coccyx)
• Proficiency in reading and writing the French language
• Be affiliated to the social security system
• Have signed an informed consent form
• be using adequate contraceptive measures, and have a negative pregnancy test (specify if urine or blood test) prior to receiving the first dose of trial medication;
• or be post-menopausal (aged over 50 with amenorrhoea for at least 12 months after stopping all exogenous hormonal treatments)
• or (if under 50) have been in amenorrhoea for at least 12 months after stopping all exogenous hormone treatments and with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels.
• or have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).

You may not qualify if:

• Coccygodynia accompanied by a dermatological lesion in the intergluteal cleft (psoriasis, pilodinial cyste, wound)
• Patients with other major pain disorders likely to interfere with pain assessment
• Hypersensitivity to capsaicin or to one of the excipients
• Adults under legal protection (guardianship, curatorship, legal protection)
• Pregnant or breast-feeding women
• Patients who have undergone total coccygectomy

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

Brest University Hospital

Brest, France

RECRUITING

Vendée Departmental Hospital

La Roche-sur-Yon, France

RECRUITING

Confluent Private Hospital Centre

Nantes, France

RECRUITING

Nantes University Hospital

Nantes, France

RECRUITING

GH Paris saint Joseph

Paris, France

RECRUITING

Rouen University Hospital

Rouen, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Capsaicin; Transdermal Patch

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies

Central Study Contacts

Amélie LEVESQUE, MD

CONTACT

+33240083912; amelie.levesque@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: September 5, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): January 8, 2027
• Study Completion (Estimated): June 8, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FR (6)