- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06023706
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia. (CAPSACOX)
April 25, 2024 updated by: Nantes University Hospital
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.
Study Overview
Status
Recruiting
Conditions
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).
Study Type
Interventional
Enrollment (Estimated)
188
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amélie LEVESQUE, MD
- Phone Number: +33240083912
- Email: amelie.levesque@chu-nantes.fr
Study Locations
-
-
-
Brest, France
- Recruiting
- Brest University Hospital
-
Contact:
- Bertrand QUINIO, MD
-
Principal Investigator:
- Bertrand QUINIO, MD
-
La Roche-sur-Yon, France
- Recruiting
- Vendée Departmental Hospital
-
Contact:
- Yves-Marie PLUCHON, MD
-
Principal Investigator:
- Yves-Marie PLUCHON, MD
-
Nantes, France
- Recruiting
- Nantes University Hospital
-
Contact:
- Amélie LEVESQUE, MD
-
Principal Investigator:
- Amélie LEVESQUE, MD
-
Nantes, France
- Recruiting
- Confluent Private Hospital Centre
-
Contact:
- Thibault RIANT, MD
-
Principal Investigator:
- Thibault RIANT, MD
-
Paris, France
- Recruiting
- GH Paris saint Joseph
-
Contact:
- Marguerite D'USSEL, MD
-
Principal Investigator:
- Marguerite D'USSEL, MD
-
Rouen, France
- Recruiting
- Rouen University Hospital
-
Contact:
- Rodrigue DELEENS, MD
-
Principal Investigator:
- Rodrigue DELEENS, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Capsaicin 179 mg cutaneous patch
Capsaicin 179 mg cutaneous patch. 1 patch applied once for 1 hour at inclusion visit. |
1 patch applied once for 1 hour
Other Names:
|
Placebo Comparator: Capsaicin low concentration patch
Capsaicin 0.04 cutaneous patch. 1 patch applied once for 1 hour at inclusion visit |
1 patch applied once for 1 hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
Time Frame: Day 60
|
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 Outcome Measures
Outcome Measure |
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
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)
|
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 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.
Time Frame: Throughout the study (an average of 5 months)
|
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.
Time Frame: Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
|
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).
Time Frame: Over 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).
Time Frame: Over 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
Time Frame: 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
|
Determination of the therapeutic response to 8% capsaicin patch
Time Frame: Day 60
|
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.
Time Frame: Between 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
|
Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.
Time Frame: At inclusion
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2023
Primary Completion (Estimated)
January 8, 2027
Study Completion (Estimated)
June 8, 2027
Study Registration Dates
First Submitted
August 1, 2023
First Submitted That Met QC Criteria
September 4, 2023
First Posted (Actual)
September 5, 2023
Study Record Updates
Last Update Posted (Estimated)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC22_0415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuropathic Pain
-
University Hospital, Clermont-FerrandFondation ApicilCompletedNeuropathic Traumatic Pain | Pain NRS ≥ 4 | Peripheral Neuropathic Pain | Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4France
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPostherpetic Neuralgia (PHN) | Chemotherapy Induced Neuropathic Pain | Diabetic Peripheral Neuropathic Pain (DPN) | HIV-related Neuropathic Pain (HIV)Colombia, Mexico, Ecuador, Peru, Venezuela
-
University Hospital, Clermont-FerrandRecruitingPeripheral Neuropathic PainFrance
-
Daiichi Sankyo Co., Ltd.CompletedCentral Neuropathic PainJapan, Korea, Republic of, Taiwan
-
Hospices Civils de LyonCompletedPharmacoresistant Neuropathic PainFrance
-
Yuhan CorporationCompletedPeripheral Neuropathic PainKorea, Republic of
-
University Hospital, Clermont-FerrandCompletedNeuropathic Pain RebelFrance
-
University Hospital, Strasbourg, FranceTerminatedPostthoracotomy Pain | Postthoracoscopy Neuropathic PainFrance
-
AstraZenecaCompletedNociceptive Pain | Peripheral Neuropathic PainUnited Kingdom
-
Ashwin ViswanathanBoston Scientific CorporationNot yet recruitingChronic Pain | Neuropathic Pain | Pain, NeuropathicUnited States
Clinical Trials on Capsaicin 179 Mg Cutaneous Patch
-
NeurogesXCompletedHIV Infections | Pain | Peripheral Nervous System Diseases
-
Samyang Biopharmaceuticals CorporationCompletedPostherpetic Neuralgia | Peripheral Nerve InjuryKorea, Republic of
-
The University of Texas Health Science Center at...CompletedNeuropathic Pain | Spinal Cord InjuriesUnited States
-
University of FloridaCompletedPain | FibromyalgiaUnited States
-
Aalborg UniversityEuropean Commission; Danish National Research FoundationCompletedProlonged Pain, EEG, Resting State Functional ConnectivityDenmark
-
Kyunghee University Medical CenterUnknown
-
Aalborg UniversityRecruiting
-
Medical University of ViennaAstellas Pharma GmbHCompleted
-
Tuula ToljamoUniversity of Helsinki; University of OuluCompleted
-
NeurogesXCompletedPain | Peripheral Nervous System Diseases | Neuralgia | Herpes Zoster | ShinglesUnited States