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The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsaicin 179 mg cutaneous patch | Experimental | Capsaicin 179 mg cutaneous patch. 1 patch applied once for 1 hour at inclusion visit. |
|
| Capsaicin low concentration patch | Placebo Comparator | Capsaicin 0.04 cutaneous patch. 1 patch applied once for 1 hour at inclusion visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin 179 Mg Cutaneous Patch | Drug | 1 patch applied once for 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amélie LEVESQUE, MD | Contact | +33240083912 | amelie.levesque@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest University Hospital | Recruiting | Brest | France |
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Double-blind
| Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2) | Drug | 1 patch applied once for 1 hour |
|
| 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. | 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. | 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. | 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.). | 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. | 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. | 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. | 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). | Between Day 0 and Day 60 |
| Vendée Departmental Hospital | Recruiting | La Roche-sur-Yon | France |
|
| Confluent Private Hospital Centre | Recruiting | Nantes | France |
|
| Nantes University Hospital | Recruiting | Nantes | France |
|
| GH Paris saint Joseph | Recruiting | Paris | France |
|
| Rouen University Hospital | Recruiting | Rouen | France |
|
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004864 | Equipment and Supplies |
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