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    Summary
    EudraCT Number:2020-001022-57
    Sponsor's Protocol Code Number:Qutenza-FM-20
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-08-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-001022-57
    A.3Full title of the trial
    The effect of Qutenza application in patients with post-operative neuropathic pain: A double-blind, randomized, controlled pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with small Qutenza patches over painful trigger points in scars after operation: A blinded study using placebo paths versus active Qutenza patch
    A.3.2Name or abbreviated title of the trial where available
    Qutenza-FM-20
    A.4.1Sponsor's protocol code numberQutenza-FM-20
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWojciech Zbigniew Pawlak
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Qutenza 179 mg kutanplaster
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal Aps
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameQutenza 179 mg cutaneous patch
    D.3.2Product code EMEA/H/C/00909
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapsaicin
    D.3.9.1CAS number 404-86-4
    D.3.9.2Current sponsor codeNO1BX04
    D.3.9.3Other descriptive nameCAPSAICIN
    D.3.9.4EV Substance CodeSUB13229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous patch
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative neuropathic pain
    E.1.1.1Medical condition in easily understood language
    Pain after nerve damage
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077974
    E.1.2Term Peripheral neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the present study is to compare the effect of local application of Qutenza® patches covering trigger points in patients with chronic pain after surgery compared to placebo patches. The effects are monitored on pain at rest and during movement, areas of pin-prick hyperalgesia and brush allodynia, detection and pain thresholds for cold and heat within these areas. Our hypothesis is that small local Qutenza® patches applied over trigger points may reduce pain at rest, during movement and decrease sensory disturbances compared with a placebo patch. The present study is a pilot study performed in order to obtain proof of con-cept for a future comparative study between small localized and large Qutenza patches.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years old
    • Patients with chronic pain for ≥3 months, with a daily VAS pain scores ≥40 mm (VAS 0-100mm, 0=no pain and 100=worst possible pain) after sur-gery
    • Patients have a score ≥7 in the neuropathic pain questionnaire DN4
    • Negative pregnancy test in fertile women.
    • Patients with at least one identifiable trigger point in relation to incision in a mobile body part or a positive outcome from our first study (7). A trigger point is defined as an area in relation to the incision from surgery, in which a light pressure from a cotton pin radiate pain to the nearby area and exudes a motor reflex causing withdrawal of the body part related to the incision. Trigger points will be identified using ultrasound scanning.
    • Skin must be intact and dry without wounds or stripes in an area of 6 cm in diameter from the trigger point
    • A written and signed informed consent to participate in the study after having fully understood the contents of the protocol and restrictions
    E.4Principal exclusion criteria
    • Patients who cannot cooperate
    • Patients who can cooperate but do not understand or speak Danish
    • Patients with allergy to the drugs used in the study, ingredients or compo-nents in the matrix and cleansing creme*
    • Women who are not using acceptable effective contraception
    • Patients suffering from other neuropathic pain conditions.
    E.5 End points
    E.5.1Primary end point(s)
    • Difference in mean changes from baseline in pain score between active and placebo treatment at times day 14, 28 and 90 on a visual analogue scale (VAS 0-100 mm 0 is no pain and 100 is worst possible pain).
    • Difference in changes from baseline of area of pin-prick hyperalgesia, cold allodynia and brush allodynia assessed using von Frey filament 60 gram, Lindblom roller and Somedic Brush, between active and placebo treatment on day 14, day 28 and day 90.
    • Difference from baseline in detection, thresholds and tolerance for cold and warmth with-in the hyperalgesia area compared to normal skin, between active and placebo treatment on day 14, day 28 and day 90. If pain relief persists assessments are performed every 14 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14, 28 and day 90
    E.5.2Secondary end point(s)
    • Time used to perform the treatment procedure from preparation of the patch to end of cleansing procedure
    • Difference in pain and discomfort between active and placebo during treatment at 15, 30, 45 and 60 minutes and after treatment assessed on a VAS scale 0-100 mm, 0 is no pain/discomfort, 100 is worst possible pain/discomfort
    • Difference in application site erythema, burning sensations, edema, pruritus, pap-ules/vesicles measured on a scale from none, slight, moderate to severe, between ac-tive and placebo treatment assessed at 15, 30, 45 and 60 minutes and 30 minutes after treatment in both groups
    • Irritation in eyes and throat, and coughing associated to the treatment assessed dur-ing and 30 minutes after treatment in both groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    15, 30, 45 and 60 minutes
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-12-31
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