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    Summary
    EudraCT Number:2016-000252-99
    Sponsor's Protocol Code Number:DRO-200/III/15/1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-000252-99
    A.3Full title of the trial
    A randomized, double-blind, multi-center, placebo-controlled, parallel group study to evaluate the efficacy and safety of an etofenamate 5% cutaneous patch applied twice daily in subjects with acute uncomplicated unilateral ankle sprain for a period of 7 consecutive days.
    Randomisierte, doppelblinde, multizentrische, placebo-kontrollierte, Parallelgruppen-Studie zur Bewertung der Wirksamkeit und Sicherheit der Anwendung eines Etofenamat 5%-Pflasters bei Patienten mit akuter, unkomplizierter, unilateraler Sprunggelenkverstauchung (Distorsion) über eine Dauer von 7 Tagen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomly ordered clinical trial to evaluate the efficacy and safety of an etofenamate 5% cutaneous patch vs. placebo in the treatment of acute uncomplicated one sided ankle sprain.
    Zufallsverteilte klinische Studie zur Bewertung der Wirksamkeit und Sicherheit der Anwendung eines Etofenamat 5%-Pflasters gegenüber Placebo bei Patienten mit akuter, unkomplizierter, einseitiger Sprunggelenkverstauchung.
    A.4.1Sponsor's protocol code numberDRO-200/III/15/1
    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 SponsorDrossapharm AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDrossapharm AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBundesinstitut für Arzneimittel und Medizinprodukte
    B.5.2Functional name of contact pointFachgebiet Klinische Prüfungen
    B.5.3 Address:
    B.5.3.1Street AddressKurt-Georg-Kiesinger-Allee 3
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53175
    B.5.3.4CountryGermany
    B.5.4Telephone number+492282074318
    B.5.5Fax number+492284355
    B.5.6E-mailklinpruefung@bfarm.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 No
    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 nameEtofenamate 5% cutaneous patch
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtofenamat
    D.3.9.1CAS number 30544-47-9
    D.3.9.3Other descriptive nameETOFENAMATE
    D.3.9.4EV Substance CodeSUB07319MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number5
    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 placeboMedicated plaster
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankle sprain, grade I or II
    Akute Sprunggelenksverstauchung, Grad I oder II
    E.1.1.1Medical condition in easily understood language
    Ankle sprain, grade I or II
    Akute Sprunggelenksverstauchung, Grad I oder II
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of an Etofenamate 5% patch applied two times a day compared with a placebo patch in patients with acute ankle sprains, in particular with regard to pain relief.
    Die Bewertung der Wirksamkeit von Etofenamat 5%-Pflaster zweimal täglich bei Patienten mit akuter Sprunggelenkverstauchung, insbesondere in Bezug auf die Schmerzlinderung.
    E.2.2Secondary objectives of the trial
    - The pain-on-movement (POM) on the Visual Analogue Scale (VAS) at Visit 4 (48 hours after initiating treatment) and at Visit 6 (96 hours after initiating treatment).
    - To assess the safety of an Etofenamate 5% patch compared with a placebo patch.
    - Der Bewegungsschmerz auf der visuellen Analogskala bei Visite 4 (48 Stunden nach Behandlungsbeginn) und bei Visite 6 (96 Stunden nach Behandlungsbeginn).
    - Die Bewertung der Sicherheit von Etofenamat 5%-Pflaster, im Vergleich zu Placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Acute uncomplicated unilateral ankle sprain, Grade I or II
    2. Enrolment within 12 hours of the injury
    3. Baseline VAS score for (investigator manipulated) pain on movement (POM) of injured ankle > 50 mm on a 100 mm VAS
    4. Adult male or female patients
    5. Age 18 to 60 years
    6. Having given written informed consent
    7. Satisfactory health as determined by the Investigator based on medical history and physical examination.
    1. Akute, unkomplizierte, einseitige Verstauchung des Sprunggelenks, Grad I oder II
    2. Verletzung erfolgte innerhalb der letzten 12 Stunden vor Einschluss
    3. Durch den Prüfer ausgelöster Ausgangsbewegungsschmerz (POM) des verletzten Sprunggelenkes ≥ 50 mm auf einer 100 mm langen visuellen Analogskala VAS
    4. Erwachsene weibliche oder männliche Patienten
    5. Patientenalter: 18-60 Jahre
    6. Vorhandene schriftliche Einwilligungserklärung nach Aufklärung bevor eine Untersuchung vorgenommen wird.
    7. Zufriedenstellender allgemeiner Gesundheitszustand, festgestellt durch den Prüfer anhand der Anamnese und körperlichen Untersuchung
    E.4Principal exclusion criteria
    1. Serious injury in the area of the foot or ankle, including fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound.
    2. Excessively hairy skin at application site.
    3. Chronic skin disorder at application site.
    4. History of excessive sweating inclusive of application site.
    5. Intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of clinical trial start.
    6. Intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed).
    7. Participation in a clinical trial within 30 days before entry or concomitantly.
    8. Drug or alcohol abuse in the opinion of the investigator.
    9. Pregnant and lactating women.
    10. Women of child-bearing potential without medically accepted contraception.
    11. Known hypersensitivity to etofenamate or one of the excipients of the patch.
    12. History of previous grade I ankle sprain (same ankle) within 6 months, or previous grade II sprain, or other significant injury to the same ankle or foot within 6 months.
    13. Patients with history of previous grade III ankle sprain (same ankle).
    14. Patients with a disease affecting the same ankle, such as synovitis, rheumatoid arthritis, arthrosis, etc.
    15. Patients suffering from symptoms of an infectious disease including swelling of any joint of the affected lower limb.
    16. Patients who had surgery of the affected lower limb within one year of clinical trial entry.
    17. Patients with significant diseases (defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the clinical trial or a disease which may influence the results of the clinical trial or the patient‟s ability to participate in the clinical trial; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease).
    18. Patients with a blood coagulation disorder.
    19. Patients who use any impermissible medication
    1. Ernsthafte Verletzung des Fußes oder des Sprunggelenkes, einschließlich Knochenbrüche, Nervenverletzungen, Bänderrisse, Muskel- oder Knorpelrisse oder offene Wunden
    2. Übermäßige Behaarung des zu behandelnden Hautareals
    3. Chronische Hauterkrankung des zu behandelnden Hautareals.
    4. Bekanntes exzessives Schwitzen einschließlich des zu behandelnden Hautareals
    5. Einnahme von nichtsteroidalen Antiphlogistika (NSAIDs) oder Schmerzmitteln innerhalb der letzten 36 Stunden vor Studienbeginn. Einnahme von Opiaten innerhalb der letzten 7 Tagen oder Corticosteroiden innerhalb der letzten 60 Tage vor Beginn der klinischen Prüfung.
    6. Einnahme von Langzeit NSAIDs oder Anwendung von topischen Arzneimitteln seit der Verletzung (Pause, Eis, Compression oder Hochlagern des Fußes (PECH) sind erlaubte Behandlungsmethoden).
    7. Teilnahme an einer anderen klinischen Prüfung innerhalb der letzten 30 Tage vor Beginn der klinischen Prüfung oder gleichzeitige Teilnahme an einer anderen klinischen Prüfung.
    8. Drogen- oder Alkoholabusus (Beurteilung durch der Prüfer)
    9. Schwangere oder stillende Frauen
    10. Gebärfähige (das heißt alle Frauen, die physiologisch in der Lage sind, schwanger zu werden), die keine akzeptable Verhütungsmethode anwenden
    11. Bekannte Überempfindlichkeit gegenüber Etofenamat oder einem der Hilfsstoffe des Pflasters
    12. Anamnese von Grad I Verstauchung (dasselbe Sprunggelenk) innerhalb der letzten 6 Monate vor Studienbeginn, oder frühere Grad II Verstauchung oder eine andere signifikante Verletzung desselben Sprunggelenkes in den letzten 6 Monaten.
    13. Anamnese von Grad III Verstauchung (dasselbe Sprunggelenk)
    14. Patienten mit einer Erkrankung desselben Sprunggelenkes wie Synovitis, rheumatoide Arthritis, Arthrose, etc.
    15. Patienten mit Symptomen einer Infektion mit Manifestation von Gelenkschwellungen der betroffenen unteren Extremität.
    16. Patienten mit vorausgegangener Operation der unteren Extremität im letzten Jahr vor Studieneinschluss.
    17. Patienten mit signifikanten Erkrankungen (definiert als Erkrankung, die in den Augen des Prüfers entweder den Patienten a.G. seiner Teilnahme an der klinischen Prüfung einem Risiko aussetzt oder eine Erkrankung, die das Ergebnis der klinischen Prüfung oder die Teilnahmefähigkeit des Patienten beeinträchtigen kann: einschließlich Personen mit einer Anamnese von gastrointestinalen Blutungen, signifikante cardiovaskuläre, Leber- oder Nierenerkrankungen).
    18. Patienten mit Blutgerinnungsstörungen
    19. Patienten, die eine nicht erlaubte Medikation verwenden.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is ankle pain-on-movement (POM) assessed by Visual Analogue Scale (VAS) at Visit 5 (72 hours after initiating treatment).
    Die primäre Wirksamkeitsvariable ist der Bewegungsschmerz (Pain-on-movement (POM)) im Sprunggelenk, der anhand der visuellen Analogskala (VAS) bei Visite 5 (72 Stunden nach Behandlungsbeginn) bestimmt wird.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 5 (72 hours after initiating treatment)
    Visite 5 (72 Stunden nach Behandlungsbeginn)
    E.5.2Secondary end point(s)
    1. Pain-on-movement (POM) at 48, 72, 96 and 168 hours measured by VAS – clinic visit
    2. AUC over time during between baseline and the first 48, 72, 96 and 168 hours for POM measured by VAS – clinic visit
    3. Pain at rest measured by VAS ( 48 and 72 hours)
    4. Ankle swelling (Figure-of-eight-method, mm) at 48, 72 and 96 hours – clinic visit
    5. Global efficacy assessments (GEA, 5 point numerical scale) at 72 and 168 hours – clinic visit
    6. Use of rescue medication at every visit except Visit 1 – clinic visit
    7. Time to meaningful/optimal reduction of pain defined as 30% (meaningful) and 50% (optimal) reduction of baseline VAS for POM. Both time points will be calculated
    8. Responder rate (defined as the number of patients achieving 50% reduction in the VAS score at 72 hours)
    1. Bewegungsschmerz (pain on movement –POM) bei der 48, 72, 96 und 168 Studen Visite anhand der VAS – klinische Visite
    2. Fläche unter der Kurve (AUC) der Bewegungsschmerz/Zeit Achsen anhand der VAS für die ersten 48, 72, 96 und 168 Stunden nach Behandlungsbeginn – klinische Visite
    3. Ruheschmerz (pain at rest-PAR) anhand der VAS (48und 72 Std. nach Behandlungsbeginn)
    4. Gelenkschwellung mittels der Figure-of-Eight-Methode (mm) – klinische Visite
    (48, 72, 96 Std. nach Behandlungsbeginn) – klinische Visite
    5. Globale Wirksamkeitsbewertungen (GEA, 5 Punkte numerische Skala) 72 und 168 Studen nach Behanldungsbeginn – klinische Visite
    6. Verbrauch an Notfallmedikation (an allen Visiten außer Visite 1) – klinische Visite
    7. Zeit bis zur bedeutsamen/optimalen Schmerzreduktion definiert als 30% (bedeutsame) und 50% (optimale) Reduktion der VAS Grundlinie für POM. Beide Punkte werden errechnet.
    8. Responder Rate definiert als die Anzahl Patienten, die eine 50% Reduktion auf der VAS Skala für POM nach 72 Stunden erreichen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Visit 4 (48h), Visit 5 (72h), Visit 6 (96h) and Visit 7 (168h)
    2. Visit 4 (48h), Visit 5 (72h), Visit 6 (96h) and Visit 7 (168h)
    3. Visit 4 (48h) and Visit 5 (72h)
    4. Visit 4 (48h), Visit 5 (72h) and Visit 6 (96h)
    5. Visit 5 (72h) and Visit 7 (168h)
    6. Every visit except Visit 1
    7. Every visit
    8. Visit 5 (72h)
    1. Visite 4 (48h), Visite 5 (72h), Visite 6 (96h) und Visite 7 (168h)
    2. Visite 4 (48h), Visite 5 (72h), Visite 6 (96h) und Visite 7 (168h)
    3. Visite 4 (48h) und Visite 5 (72h)
    4. Visite 4 (48h), Visite 5 (72h) und Visite 6 (96h)
    5. Visite 5 (72h) und Visite 7 (168h)
    6. Jede Visite ausser Visite 1
    7. Jede Visite
    8. Visite 5 (72h)
    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 Yes
    E.6.4Safety Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.6Cross over No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 No
    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
    LPLV
    Letzter Besuch des letzten Patienten.
    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 months5
    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: 152
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state152
    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.
    Keine.
    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 Decision2016-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-13
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