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    Summary
    EudraCT Number:2006-000383-88
    Sponsor's Protocol Code Number:CSC/Keto-01/06
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-30
    Trial 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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-000383-88
    A.3Full title of the trial
    A Multicenter, Parallel-group, Double-blind, Placebo Controlled and Randomized Clinical Study to Assess the Efficacy and Safety of Ketoprofen 10% Cutaneous Spray versus Placebo in Patients with Acute Ankle Sprains (AAS)
    A.4.1Sponsor's protocol code numberCSC/Keto-01/06
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCSC Pharmaceuticals Handels GmbH
    B.1.3.4CountryAustria
    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 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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Ketospray 10%-Spray
    D.2.1.1.2Name of the Marketing Authorisation holderCSC Pharmaceuticals Handels GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.4Pharmaceutical form Cutaneous spray*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNKetoprofen
    D.3.9.1CAS number 22071-15-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100/1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 spray*
    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
    Painful, acute ankle sprains, as a model of general traumatic soft-tissue injuries
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10002549
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary study objectives: To evaluate the efficacy of Ketoprofen 10% Cutaneous Spray compared to placebo in patients with acute ankle sprains.
    E.2.2Secondary objectives of the trial
    Secondary study objectives: To evaluate the safety of Ketoprofen 10% Cutaneous Spray in patients with acute ankle sprains.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subject diagnosed with an acute ankle sprain of external lateral ligament defined as degree I or II in the O’Donoghue classification or as stage I or II in the Castaing classification (for details see references as well as short reminder at the end of this document), and fulfilling the following criteria:
    - Post-traumatic sprain caused by medial inversion of the ankle.
    - Pain on active motion assessed by the patient must correspond to ≥ 50 mm VAS at baseline.
    - Uncomplicated ankle sprain, i.e. treatable without surgery, and including injuries not associated with concomitant problems that contraindicate early motion and rehabilitation.
    - Onset within 48 hours prior to the first visit, medically untreated as yet except for paracetamol (last dose not later than 6h prior to the baseline visit) or other type II analgesics e.g. dextropropoxifen (last dose not later than 12h prior to the baseline visit) or ice packs (last application not later than 1 hour prior to the baseline visit).
    · Male or female outpatients
    · Aged 18-65 years
    · If female of childbearing potential:
    - agree to maintain reliable birth control (oral contraceptive, IUDs, sterilized partner) throughout the study.
    - or with negative (urine) pregnancy test in countries where required (by the Ethic’s Committee).
    · Subject who, in the opinion of the investigator, would understand the meaning of the information sheet, would be co-operative and sufficiently reliable to use the medication as instructed, complete the diary and return for follow-up visits.
    · Subject has provided written informed consent prior to undergoing any study procedure.
    E.4Principal exclusion criteria
    Criteria concerning ankle sprain:
    Subject:
    · Who has a complicated ankle sprain, i.e.
    - Requiring surgery
    - Not meeting degree I or II or stage I or II for ankle sprain according to O’Donoghue and Castaing classification, respectively.
    - Where radiography is indicated according to the Ottawa rules.
    · Who has undergone another course of treatment for the ankle sprain e.g. cast or other immobilizing (i.e. inhibition of dorso-flexion) bandage or system.
    · Who has recurrent ankle sprain (i.e. a previous episode within the last 6 months).
    · Who has bilateral ankle sprain.
    · Who has had a major surgery of the affected joint during the 6 months preceding inclusion.

    Criteria concerning previous and concomitant medication and other therapy:
    Subject:
    · Who has started treatment with antidepressants, muscle relaxants or tranquilizers within 1 month of enrolment, or who is likely to change the dose of such concomitant drugs during the course of the study.
    · Who is taking or has taken any form, including topical, of opioid, NSAID (except for low dose aspirin 200mg or less that was started at least 30 days prior to enrolment, and that will not be changed during the study), or any other analgesic within 7 days of inclusion (or 15 days for oxicams).
    · Who is unable to walk without aid or using crutches.
    · Who has taken any other investigational drug within the past 30 days.
    · Receiving therapy with agents known or likely to interact with study drug, see section 8 of protocol.

    Criteria concerning the subject:
    Subject:
    · Who is pregnant or breast-feeding.
    · Who has a known hypersensitivity to ketoprofen, or who has an allergy manifested by attacks of asthma, urticaria, or acute rhinitis following treatment with aspirin or other agents with cyclo- oxygenase inhibiting activity such as non-steroidal anti-inflammatory drugs (NSAIDs).
    · Who has a known hypersensitivity to paracetamol.
    · Who is suffering from known liver, kidney, cardiovascular, pulmonary or hematological disease.
    · Who is suffering from phlebitis.
    · Who has suffered from an ulcer, gastrointestinal bleeding and/or perforation within 2 years prior to the trial.
    · With evidence or history of drug or alcohol abuse.
    · Who has previously participated in this clinical study.
    · Who has skin lesions or wounds in the affected area on the ankle to be treated.
    · With mental impairment limiting the ability to comply with study requirements.
    · Who, in the opinion of the investigator, is unable or unwilling to complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Pain on Active Motion VAS (mm) between Baseline and Day 3.
    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 Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 240
    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 Decision2006-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-07
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