A Phase 4 interventional study of Lidocaine patch 5% and Capsaicin 8% Patch in Neuropathic Pain, sponsored by University Hospital, Antwerp. Terminated at 13 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University Hospital, Antwerp · Phase 4, Interventional, and Treatment
Among 22 studies testing capsaicin in Neuralgia — 4 open to participants now, 4 under way, 2 of them phase 3. Capsaicin · Neuralgia.
Among the 22 studies testing capsaicin in Neuralgia, this one is the 14th largest by enrollment of the 20 interventional ones, is the only one that started in 2018, is one of 3 in phase 4, and was the 15th registered.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's enrollment of 33 is below the median of 52 across 831 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →4 of the 22 studies testing capsaicin in Neuralgia are open now, in 1 country. Each count lists the studies.
Capsaicin: first FDA approval 2009 (QUTENZA), first EMA approval 2009. What it is approved for, and how studies give it, is on its page →
Of the 152 Neuralgia studies recruiting now, 76 (50%) set no upper age limit and 44 (29%) stop at 75 or younger; 8 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
Median enrollment 67 across the 20 interventional studies. Of the 16 that completed or were terminated, 3 (19%) have results posted.
10 of 22 have an industry lead sponsor. The 10 most frequent:
University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
University Hospital, Antwerp has 2 studies filed under Neuralgia — fewer than ten, so there is no comparison to draw.
2 of the studies testing capsaicin in Neuralgia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06023706Phase 3Nantes University HospitalStudy Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia. | 2027-05-08 |
| NCT07602387Hospital Ambroise Paré ParisChemotherapy Induced Peripheral Neuropathy by Taxanes and Capsaicin 8%. | 2027-03 |
Among the 22 studies testing capsaicin in Neuralgia, from their registry updates:
Evaluation of topical treatment with lidocaine 5% patch (daily administration) or capsaicin 8% patch (periodic administration - upon reoccurrence of pain symptoms) in adult patients suffering from localized neuropathic pain (LNP) across a wide variety of etiologies, with a duration between 1 and 24 months (subacute to chronic neuropathic pain (NP)).
A multicentre, randomized, open-label comparative trial evaluating topical treatment options versus oral systemic treatment in adult patients suffering from localized neuropathic pain (LNP) syndromes. A wide variety of peripheral neuropathic pain syndromes will be included such as post-herpetic neuralgia (PHN), post-surgical NP/post-traumatic NP/scar pain, post-amputation NP, post-radiation therapy NP, complex regional pain syndrome (CRPS) type 1. In contrast to most (or even all) commercial clinical studies we will not limit the inclusion to one or two distinct neuropathic pain syndromes such as post-herpetic neuralgia (inclusion based on etiology of the neuropathic syndrome). In this pragmatic trial we will however include all patients suffering from a clinical neuropathic syndrome with distinct clinical features such as hyperalgesia/allodynia, presence of spontaneous positive sensory phenomena and lasting for more than 3 months without making any exclusion based on etiology. Initial pain intensity indicates the presence of either moderate or severe pain in these adult patients (NRS 4/10).
Patients eligible for inclusion in this study must fulfil all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours.
Drug: Lidocaine patch 5%
Capsaicin 8% patches need to applied in a hospital setting during 1 hour. Re-application of these capsaicin patches will be performed upon re-occurrence of painful symptoms (mostly after 12 weeks - so not after a fixed time interval). Application of capsaicin patches will be carried out in a hospital setting (+/- 3 hours procedure).
Drug: Capsaicin 8% Patch
Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe. In European clinical practice, up-titration of the dose is often carried out over a longer time-period. This study thus includes up-titration schedule for pregabalin over a period of 4 weeks. If patients develop side-effects during the intake/uptitration of pregabalin this treatment can be stopped and switched to gabapentin (300mg capsules). Gabapentin will always be the back-up treatment for failed systematic treatment with pregabalin. Dose of gabapentin will be uptitrated to maximum 1200mg per day.
Drug: Pregabalin
Application of Lidocaine 5% patch for 12 hours.
Application of Capsaicin 8% patch for
Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.
Health-related quality of life questionnaire
To determine if topical treatment significantly improves health-related quality of life compared to systemic treatment in adult patients suffering from localized neuropathic pain across a wide variety of etiologies (LNP), with a duration between 1 and 24 months.
Time frame: 24 months
Pain relief
Reduction in pain intensity (PI-NRS), time to worsening of the pain (PI-NRS and NPSI) and use of rescue medication (MSQ III-R)
Time frame: from week 0 up to 26 weeks
Health-related quality of life
AUC for EQ-5D-5L measurements, global perceived effect (GPE), effect on mood (HADS), quality of sleep (NRS and ISI).
Time frame: from week 0 up to 26 weeks
Drug tolerance
Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.
Time frame: from week 0 up to 26 weeks
Functional status of the patient
Impact of pain on functioning (Interference - BPI), participation in activities (Utrecht Work Engagement Scale), Work Productivity and Activity Impairment (WPAI).
Time frame: from week 0 up to 26 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidoderm · Capsaicin
University Hospital, Antwerp →