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    Summary
    EudraCT Number:2014-005574-11
    Sponsor's Protocol Code Number:Pennsaid-2014/P-3-01
    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:2015-04-07
    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 number2014-005574-11
    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 Diclofenac 2%
    (w/w) cutaneous solution applied twice daily in patients with acute
    uncomplicated unilateral ankle sprain for a period of 7 consecutive days.
    Abbreviated title: Randomized, controlled, double-blind, multi-center trial
    to evaluate the efficacy and safety of a diclofenac 2% cutaneous solution
    vs. placebo in the treatment of acute uncomplicated unilateral ankle sprain
    Eine randomisierte, doppelblinde, multizentrische, placebo-kontrollierte,
    Parallelgruppen Studie, um die Wirksamkeit und Sicherheit einer
    2% (w/w) Diclofenac kutanen Lösung zweimal pro Tag in Patienten mit
    akuter unkomplizierter einseitiger Sprunggelenksverstauchung für einen
    Zeitraum von 7 aufeinanderfolgenden Tagen zu bewerten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of Diclofenac for Treatment of Pain and inflammation of Acute Soft Tissue Injury/ Ankle Sprain
    Clinical study to evaluate the efficacy and safety of a 2% Diclofenac cutaneous solution vs. placebo in the treatment of acute uncomplicated
    unilateral ankle sprain
    Klinische Studie zur Bewertung der Wirksamkeit und Sicherheit der
    Anwendung einer 2%-Diclofenac Lösung gegenüber Placebo zur
    Behandlung von akuter, unkomplizierter, einseitiger
    Sprunggelenksverstauchung
    A.4.1Sponsor's protocol code numberPennsaid-2014/P-3-01
    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 SponsorNuvo Research GmbH
    B.1.3.4CountryGermany
    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 supportNuvo Research GmbH
    B.4.2CountryGermany
    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 pointBundesinstitut
    B.5.3 Address:
    B.5.3.1Street AddressKurt-Kiesinger Allee 3
    B.5.3.2Town/ cityBonn
    B.5.3.3Post code53175
    B.5.3.4CountryGermany
    B.5.4Telephone number+49228 207 4318
    B.5.5Fax number+49228 207 4355
    B.5.6E-mailct@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 namePennsaid 2 % cutanous solution
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNDiclofenac
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDiclofenac Sodium
    D.3.9.4EV Substance CodeSUB01674MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 solution
    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
    Treatment of pain and Inflammation associated Acute Soft Tissue Injury/Ankle Sprain
    Behandlung von Schmerzen und Entzündungen bei akuter Weichteilverletzung/Knöchelverstauchung
    E.1.1.1Medical condition in easily understood language
    To assess the efficacy of diclofenac sodium 2% w/w cutaneous solution for treatment of Pain and Inflammation associated with acute soft tissue injury/ankle sprain
    Beurteilung der Wirksamkeit von topischer Diclofenac-Natrium-Lösung 2 % w/w zur Behandlung von Schmerzen und Entzündung bei akuter Weichteilverletzung/Knöchelverstauchung.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10002549
    E.1.2Term Ankle sprain
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is:
    To assess the efficacy of diclofenac sodium 2% w/w cutaneous solution for the treatment of Pain and Inflammation associated with acute soft tissue injury/ankle sprain
    Die primäre Zielsetzung dieser Studie ist:
    Die Bewertung der Wirksamkeit von Diclofenac 2%-Lösung bei Patienten mit akuter Sprunggelenkverstauchung, insbesondere in Bezug auf die Schmerz- und Entzündungslinderung.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of diclofenac sodium 2% w/w cutaneous solution for treatment of Pain and Inflammation associated with acute soft tissue injury/ankle sprain.
    Beurteilung der Sicherheit und Verträglichkeit von topischer Diclofenac-Natrium-Lösung 2 % w/w zur Behandlung von Schmerzen und Entzündung bei akuter Weichteilverletzung/Knöchelverstauchung.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Experiencing an acute grade I or II sprain of the lateral ankle as assessed by the investigator within 12hrs of injury.
    2. Male or female aged 18 – 75 years
    3. Have POM of > 50mm on a 100mm visual analogue scale (VAS) and no use of pain medication within 12hrs preceding randomization
    4. Willing and able to provide informed consent
    1.Eine akute Verstauchung 1. oder 2. Grades des äußeren Knöchels haben, die vom Prüfarzt innerhalb von 12 Std. nach der Verletzung festgestellt wurde.
    2.Männlich oder weiblich und im Alter von 18 bis 75 Jahren sein.
    3.Einen POM von > 50 mm auf einer 100-mm visuellen Analogskala (VAS) aufweisen und dürfen innerhalb von 12 Std. vor der Randomisierung keine Schmerzmittel eingenommen haben.
    4.Bereit und in der Lage sein, eine Einwilligungserklärung abzugeben.
    E.4Principal exclusion criteria
    1.Any concurrent injury affecting the lower extremities that is painful at rest or on movement that could affect mobilization of the patient
    2.Use of topical analgesics or anti-inflammatories during the previous 30 days in the affected ankle
    3.A grade I sprain of the same ankle within 3 months
    4.A grade II or III sprain or any other significant injury or surgery of the same ankle/foot within 6 months of study start
    5.Pain or instability in ankle attributable to previous ankle sprain
    6.Any other trauma or ankle sprain attributed to a known disease affecting the ligaments.
    7.Subjects with known hypersensitivity to diclofenac, aspirin (acetylsalicylic acid [ASA]) or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol. This includes subjects exhibiting aspirin or other NSAID-induced symptoms, including bronchospasm, rhinitis, and urticaria or other NSAID-induced allergic symptoms.



    1. Eine gleichzeitige Verletzung der unteren Extremitäten aufweisen, die im Ruhezustand oder bei Bewegung schmerzhaft ist und die Mobilisierung des Studienteilnehmers beeinträchtigen könnte.
    2. In den vorangegangenen 30 Tagen topische Analgetika oder Antiphlogistika auf dem betroffenen Knöchel angewandt haben.
    3. Innerhalb von 3 Monaten vor Studienbeginn eine Verstauchung 1. Grades am selben Knöchel hatten.
    4. Innerhalb von 6 Monaten vor Studienbeginn eine Verstauchung 2. oder 3. Grades oder eine andere signifikante Verletzung oder Operation am selben Knöchel/Fuß hatten.
    5. Unter Schmerzen oder Instabilität an dem betroffenen Knöchel leiden, die auf eine frühere Verstauchung des Knöchels zurückzuführen sind.
    6. Eine andere Verletzung oder eine Verstauchung des Knöchels aufgrund einer Erkrankung haben, die die Bänder beeinträchtigt.
    7. Studienteilnehmer mit einer bekannten Überempfindlichkeit gegenüber Diclofenac, Aspirin (Acetylsalicylsäure [ASS]) oder einem anderen nichtsteroidalen Antirheumatikum (non-steroidal anti-inflammatory drug, NSAID), Dimethylsulfoxid (DMSO) oder Ethanol. Dies umfasst auch potentielle Studienteilnehmer, bei denen Aspirin- oder andere NSAID-induzierte Symptome einschließlich Bronchospasmus, Rhinitis und Urtikaria oder andere NSAID-induzierte allergische Symptome auftreten.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Pain on movement (POM) from day 1 to day 5
    Veränderung des POM von Tag 1 bis Tag 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to 5 of the POM
    Tag 1 bis 5 der POM
    E.5.2Secondary end point(s)
    Change in POM from day 1 to day 3 and from day 1 to day 8
    Response to treatment: Frequency of Meaningful Improvement in POM (50% reduction or more in POM from day 1)
    Number Needed To Treat computed for meaningful pain relief (50% reduction or more in POM from Day 1)
    Time to meaningful pain relief (time to 50% reduction in POM from Day 1)
    PAR on days 3,5, and 8
    Tenderness (algometer) on days 3,5, and 8
    Ankle joint function (Karlsson Scoring Scale) on days 3, 5, and 8
    Swelling measured using the “figure-of-eight” method on days 3, 5, and 8
    Rescue Medication use
    PGAB and PGAS at day 5 and day 8.
    Exploratory efficacy endpoints:
    •Cumulative proportional responders analysis (cumulative distribution of percent decrease from day 1 in POM)
    •Two alternative definitions of meaningful pain relief will also be analysed:
    -A reduction in POM of 40mm from Day 1
    -A POM of < 30mm
    Veränderung des POM von Tag 1 bis Tag 3 und von Tag 1 bis Tag 8
    Ansprechen auf die Behandlung: Häufigkeit signifikanter Verbesserung des POM (Reduzierung des POM um 50 % oder mehr ab Tag 1)
    Number Needed To Treat, berechnet für signifikante Schmerzlinderung (Reduzierung des POM um 50 % oder mehr ab Tag 1)
    Zeit bis zur signifikanten Schmerzlinderung (Zeit bis zur Reduzierung des POM um 50 % ab Tag 1)
    PAR an den Tagen 3, 5 und 8
    Druckschmerz (Algometer) an den Tagen 3, 5 und 8
    Funktionsfähigkeit des Sprunggelenks (Karlsson-Scoring-Skala) an den Tagen 3, 5 und 8
    Schwellung, gemessen anhand der „Figure-of-Eight“-Methode an den Tagen 3, 5 und 8
    Verwendung von Notfallmedikation
    PGAB und PGAS an den Tagen 5 und 8
    Exploratorische Wirksamkeitsendpunkte:
    •Kumulierte proportionale Responder-Analyse (kumulierte Verteilung der prozentualen Reduzierung des POM ab Tag 1)
    •Zwei alternative Definitionen signifikanter Schmerzlinderung werden ebenfalls analysiert:
    -Reduzierung des POM um 40 mm ab Tag 1
    -POM von < 30 mm
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. day 1,3 , 5 and 8: POM, PAR, tenderness, ankle swelling and ankle function
    2. all days use of rescue medication
    1. Tag 1, 3, 5 und 8: POM, PAR, Schmerzempfinden, Schwellung und Funktion des Knöchels
    2. an allen Tagen Verwendung von Reservemedikation
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state124
    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 Decision2015-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-21
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