Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Capsaicin 179 Mg Cutaneous Patch
Drug1 patch applied once for 1 hour
Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
Drug1 patch applied once for 1 hour
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Capsaicin 179 mg cutaneous patchExperimental treatment 1 intervention
Group B: Capsaicin low concentration patchPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Day 60Secondary outcomes
1
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.
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)2
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.
Time frame
Throughout the study (an average of 5 months)3
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.
Time frame
Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.4
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.
Time frame
Over 5 monthsSponsors and contacts
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Source ClinicalTrials.gov