Coccyx DisorderPhase 3CAPSACOXNCT06023706
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
A Phase 3 study testing Capsaicin 179 Mg Cutaneous Patch and Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2) in people with Coccyx Disorder and Neuropathic Pain, run by Nantes University Hospital at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccyx Disorder, Neuropathic Pain, Coccygodynia
- What is being tested?
- Capsaicin 179 Mg Cutaneous Patch and Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Nov 2023to 8 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old at the pre-inclusion visit
- 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
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- Be affiliated to the social security system
- Have signed an informed consent form
- Women must meet one of the following criteria at the time of inclusion:
- 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).
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Brest University Hospital
Brest
Bertrand QUINIO, MD
Bertrand QUINIO, MD
- Recruiting
Vendée Departmental Hospital
La Roche-sur-Yon
Yves-Marie PLUCHON, MD
Yves-Marie PLUCHON, MD
- Recruiting
Confluent Private Hospital Centre
Nantes
Thibault RIANT, MD
Thibault RIANT, MD
- Recruiting
Nantes University Hospital
Nantes
Amélie LEVESQUE, MD
Amélie LEVESQUE, MD
- Recruiting
GH Paris saint Joseph
Paris
Marguerite D'USSEL, MD
Marguerite D'USSEL, MD
- Recruiting
Rouen University Hospital
Rouen
Rodrigue DELEENS, MD
Rodrigue DELEENS, MD
About this study
Official title: Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
Read the 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
- Being tested
- Capsaicin 179 Mg Cutaneous Patch, Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 179 Mg Cutaneous PatchDrug
Also called qutenza
1 patch applied once for 1 hour
Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)Drug
1 patch applied once for 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin 179 mg cutaneous patch | Experimental | Capsaicin 179 mg cutaneous patch.
1 patch applied once for 1 hour at inclusion visit. Receives: 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 Receives: Drug: Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Tolerability will be assessed by the evolution over time of the pain intensity in standing position in the treated zone as measured on an 11 point numeric rating scale at time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.
Measured: 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.
Safety will be assessed by recording and describing adverse events throughout the study.
Measured: 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.
The timecourse of the analgesic effect will be measured by the Patients' Global Impression of Change (PGIC) scale and the area under the pain intensity score in sitting position as measured Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
Measured: 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).
Care consumption will be assessed over 5 months using the Medication Quantification Scale (MQS), which provides a standardised assessment of consumption of analgesics and co-antalgesics.
Measured: Over 5 months
Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
Care consumption will be assessed over 5 months using a self-diary in which patients will enter the dates of medical consultations (psychiatry, rheumatology, general medicine, etc.), para-medical consultations and/or complementary medical consultations (physiotherapy, acupuncture, osteopathy, psychotherapy, etc.).
Measured: Over 5 months
Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months
The evaluation of cost-utility will be assessed as the ratio of the incremental cost-utility (RICU in cost per QALY gained) comparing the treatment with 8% capsaicin patch with usual practice according to the collective perspective and a 5-month horizon. QALYS will be calculated using patients' lifespan and a utility score obtained from responses to the EQ-5D-5L generic quality of life questionnaire.
Measured: Over a time horizon of 5 months
Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.
Subgroup analysis according to the presence or absence of a sacrococcygeal mobility disorder at inclusion for the primary endpoint and the first two secondary endpoints.
Measured: At inclusion
Determination of the therapeutic response to 8% capsaicin patch
Measurement of the association between the patient's intrinsic clinical parameters and a therapeutic response to capsaicin defined by a PGIC ≤2.
Measured: Day 60
Sensitivity study to compare results on the primary endpoint by comparing data from the PGI-C and a comparison of the two numerical pain assessments at Day 0 and Day 60.
Comparison of the classification of patients as success-failure between PGI-C values at Day 60 (success if PGI-C≤2) and numerical pain assessments between Day 0 and Day 60 (success if there is a reduction of at least 2 points on the EN).
Measured: Between Day 0 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start8 Nov 2023
- Primary completion8 May 2027 (estimated)
- Study completion8 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023706
- Sponsor's protocol ID
- RC22_0415
- Acronym
- CAPSACOX
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided