Back to resultsStudy Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia. (CAPSACOX)
Primary Purpose
Coccyx Disorder, Neuropathic Pain, Coccygodynia
Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Capsaicin 179 Mg Cutaneous Patch
Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
Sponsored by
About this trial
This is an interventional treatment trial for Coccyx Disorder
Eligibility Criteria
Inclusion Criteria: >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, infiltration (for hypermobile coccygodynia) 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 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). Exclusion Criteria: 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
Sites / Locations
- Brest University Hospital
- Vendée Departmental Hospital
- Confluent Private Hospital Centre
- Nantes University Hospital
- GH Paris saint Joseph
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Capsaicin 179 mg cutaneous patch
Capsaicin low concentration patch
Arm Description
Capsaicin 179 mg cutaneous patch. 1 patch applied once for 1 hour at inclusion visit.
Capsaicin 0.04 cutaneous patch. 1 patch applied once for 1 hour at inclusion visit
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.).
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.
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.
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.
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).
Full Information
NCT ID
NCT06023706
First Posted
August 1, 2023
Last Updated
September 7, 2023
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06023706
Brief Title
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Acronym
CAPSACOX
Official Title
Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2027 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coccyx Disorder, Neuropathic Pain, Coccygodynia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capsaicin 179 mg cutaneous patch
Arm Type
Experimental
Arm Description
Capsaicin 179 mg cutaneous patch.
1 patch applied once for 1 hour at inclusion visit.
Arm Title
Capsaicin low concentration patch
Arm Type
Placebo Comparator
Arm Description
Capsaicin 0.04 cutaneous patch.
1 patch applied once for 1 hour at inclusion visit
Intervention Type
Drug
Intervention Name(s)
Capsaicin 179 Mg Cutaneous Patch
Other Intervention Name(s)
qutenza
Intervention Description
1 patch applied once for 1 hour
Intervention Type
Drug
Intervention Name(s)
Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
Intervention Description
1 patch applied once for 1 hour
Primary Outcome Measure Information:
Title
to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
Description
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.
Time Frame
Day 60
Secondary Outcome Measure Information:
Title
Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days
Description
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.
Time Frame
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)
Title
Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study.
Description
Safety will be assessed by recording and describing adverse events throughout the study.
Time Frame
Throughout the study (an average of 5 months)
Title
Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study.
Description
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.
Time Frame
Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
Title
Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
Description
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.
Time Frame
Over 5 months
Title
Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
Description
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.).
Time Frame
Over 5 months
Title
Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months
Description
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.
Time Frame
Over a time horizon of 5 months
Title
Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.
Description
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.
Time Frame
At inclusion
Title
Determination of the therapeutic response to 8% capsaicin patch
Description
Measurement of the association between the patient's intrinsic clinical parameters and a therapeutic response to capsaicin defined by a PGIC ≤2.
Time Frame
Day 60
Title
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.
Description
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).
Time Frame
Between Day 0 and Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>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, infiltration (for hypermobile coccygodynia)
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
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).
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie LEVESQUE, MD
Phone
+33240083912
Email
amelie.levesque@chu-nantes.fr
Facility Information:
Facility Name
Brest University Hospital
City
Brest
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand QUINIO, MD
First Name & Middle Initial & Last Name & Degree
Bertrand QUINIO, MD
Facility Name
Vendée Departmental Hospital
City
La Roche-sur-Yon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves-Marie PLUCHON, MD
First Name & Middle Initial & Last Name & Degree
Yves-Marie PLUCHON, MD
Facility Name
Confluent Private Hospital Centre
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibault RIANT, MD
First Name & Middle Initial & Last Name & Degree
Thibault RIANT, MD
Facility Name
Nantes University Hospital
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie LEVESQUE, MD
First Name & Middle Initial & Last Name & Degree
Amélie LEVESQUE, MD
Facility Name
GH Paris saint Joseph
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marguerite D'USSEL, MD
First Name & Middle Initial & Last Name & Degree
Marguerite D'USSEL, MD
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigue DELEENS, MD
First Name & Middle Initial & Last Name & Degree
Rodrigue DELEENS, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
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