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Neuropathic PainPhase 4PELICANNCT03348735

Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment

A Phase 4 study testing Lidocaine patch 5%, Capsaicin 8% Patch and Pregabalin in people with Neuropathic Pain, run by University Hospital, Antwerp at 13 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain
What is being tested?
Lidocaine patch 5%, Capsaicin 8% Patch and Pregabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
13 sitesBelgium
Study dates
3 Dec 2018to 19 Apr 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Age < 18;
  • Pregnant and breastfeeding women;
  • Infection in the painful skin region;
  • Poorly healed or non-healed wound or scar in the painful skin region as well as presence of cutaneous abnormalities (non-intact skin barrier) within the painful skin region related to dermatological conditions;
  • Known and/or strong suspicion of allergy to the study medication, known skin disorder (resulting in disruption of the normal skin barrier);
  • Previous treatment with any of the three medications included in the study protocol for the same painful area within the last 12 months at the time of screening;
  • Risk of heart failure and/or renal failure.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Belgium13 sites

  • AZ Monica (campus Antwerpen)

    Antwerp, 2018

  • AZ Klina

    Brasschaat, 2930

  • AZ Sint Jan Brugge

    Bruges, 8000

  • UVC Brugmann

    Brussels, 1020

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • University hospital Antwerp

    Edegem, Antwerp, 2650

  • Ziekenhuis Oost-Limburg (ZOL

    Genk, 3600

  • Universitair Ziekenhuis Gent (UZG)

    Ghent, 9000

  • UZ Brussel

    Jette, 1090

  • Universitair Ziekenhuis Leuven (UZL)

    Leuven, 3000

  • Hopital Universitaire Sart Tilman de Liège (ULg) (CHU)

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

  • AZ Turnhout

    Turnhout, 2300

Other trials in Belgium

About this study

Official title: Safety, Efficacy and Patient Acceptability of Topical Treatment Versus Systemic Treatment: a Randomized, Multicentre, Comparative Pragmatic Trial in Adult Patients Suffering From Diverse Localized Neuropathic Pain (LNP) Syndromes

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)).

Read the detailed description

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).

Being tested
Lidocaine patch 5%, Capsaicin 8% Patch, Pregabalin
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine patch 5%Drug

    Application of Lidocaine 5% patch for 12 hours.

  • Capsaicin 8% PatchDrug

    Application of Capsaicin 8% patch for

  • PregabalinDrug

    Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.

Study groups in NCT03348735
Study groupRoleWhat they receive
Lidocaine patch 5%ExperimentalLidocaine 5% medicated plasters will be applied daily, during 12 consecutive hours.
Receives: Drug: Lidocaine patch 5%
Capsaicin 8% patchExperimentalCapsaicin 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).
Receives: Drug: Capsaicin 8% Patch
PregabalineActive comparatorOral 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.
Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

Secondary outcomes (4)

  1. 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)

    Measured: from week 0 up to 26 weeks

  2. 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).

    Measured: from week 0 up to 26 weeks

  3. Drug tolerance

    Percentage of patients without systemic drug related side effects, percentage of patients who discontinue the study drug.

    Measured: from week 0 up to 26 weeks

  4. 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).

    Measured: from week 0 up to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2017
  2. Study start3 Dec 2018
  3. Primary completion19 Apr 2021
  4. Study completion19 Apr 2021

Why it stopped: Low inclusion rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multicentre, randomized, open-label comparative trial evaluating topical treatment options (lidocaine 5% or capsaicine 8% patch) versus oral systemic treatment (pregabaline as standard of care) in adult patients suffering from localized neuropathic pain (LNP) syndromes.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03348735
Sponsor's protocol ID
R017007
Acronym
PELICAN
Status last verified
Apr 2021
First submitted
16 Nov 2017
Last updated
28 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hans GH, Almeshal D, Vanlommel L, Roelant E, Verhaegen I, Smits E, Van Boxem K, Fontaine R, Investigators Team TP. Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study. Pain Res Manag. 2023 Apr 14;2023:7708982. doi: 10.1155/2023/7708982. eCollection 2023.

    PubMed 37089721

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine patch 5%, Capsaicin 8% Patch and Pregabalin in people with Neuropathic Pain, run by University Hospital, Antwerp at 13 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low inclusion rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life questionnaire (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03348735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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