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    Summary
    EudraCT Number:2011-004497-28
    Sponsor's Protocol Code Number:0028022
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-14
    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 ConcernedFinland - Fimea
    A.2EudraCT number2011-004497-28
    A.3Full title of the trial
    A RANDOMISED, MULTICENTRE, TWO-ARM, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, COMPARATIVE EFFICACY AND SAFETY CLINICAL STUDY OF IBUPROFEN 5% ROLL-ON GEL IN ADULT HUMAN PATIENTS WITH PAIN RELATED TO UNCOMPLICATED ANKLE INJURIES
    KAHDEN RINNAKKAISRYHMÄN SATUNNAISTETTU, KAKSOISSOKKOUTETTU, LUMEKONTROLLOITU KLIININEN MONIKESKUSTUTKIMUS, JOSSA TUTKITAAN 5 PROSENTTISEN IBUPROFEENI ROLL-ON GEELIN TEHOA JA TURVALLISUUTTA AIKUISILLA, JOILLA ON KOMPLISOITUMATTOMASTA NILKKAVAMMASTA JOHTUVAA KIPUA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of ibuprofen 5 % roll-on gel compared to placebo roll-on gel in patients who have uncomplicated ankle injuries with pain
    A.3.2Name or abbreviated title of the trial where available
    Ibu roll-on
    A.4.1Sponsor's protocol code number0028022
    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 SponsorOrion Pharma
    B.1.3.4CountryFinland
    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 supportOrion Pharma
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrion Corporation Orion Pharma
    B.5.2Functional name of contact pointclinicaltrials@orionpharma.com
    B.5.3 Address:
    B.5.3.1Street AddressTengströminkatu 8
    B.5.3.2Town/ cityTurku
    B.5.3.3Post codeFI-20360
    B.5.3.4CountryFinland
    B.5.4Telephone number+35810426 2349
    B.5.5Fax number+35810426 2896
    B.5.6E-mailclinicaltrials@orionpharma.com
    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 Yes
    D.2.1.1.1Trade name Ibustick 50 mg/g gel
    D.2.1.1.2Name of the Marketing Authorisation holderFarmasierra Laboratorios S.L
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Gel
    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 INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50.0
    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 placeboGel
    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
    Pain related to uncomplicaated ankle injuries.
    E.1.1.1Medical condition in easily understood language
    Pain related to uncomplicaated ankle injuries.
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10002545
    E.1.2Term Ankle injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 the study is to evaluate the efficacy of Ibuprofen 5% roll-on gel versus placebo roll-on gel in human adult patients for the treatment of pain related to uncomplicated ankle injuries.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the safety of Ibuprofen 5% roll-on gel compared with placebo roll-on gel in human adult patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained.
    2. Male and female patients, age in the range of 18-45 years (inclusive).
    3. Patients with pain related to uncomplicated ankle injuries (in case of doubt whether it is complicated an X-ray should be taken).
    4. Pain related to ankle injuries is scored as moderate or severe by the patient and the injury is less than 24 hours old.
    5. Patients with normal or clinically non-significant findings as determined by baseline history, physical examination and vital signs (blood pressure, heart rate and axillary temperature).
    6. Comprehension of the nature and purpose of the study and compliance with the protocol requirements.
    7. Negative urine pregnancy test (for females only).
    E.4Principal exclusion criteria
    1. Known hypersensitivity to aspirin or any non-steroidal anti-inflammatory drugs (NSAID).
    2. Known history of asthma.
    3. Known history of gastric or peptic ulcer or bleeding.
    4. Known history of malignancy or other serious diseases.
    5. Known history of skin allergy.
    6. Known history of cardiac, renal or hepatic insufficiency.
    7. Presence of bruises or rash on the skin of ankle.
    8. Presence of skin lesions like eczema or psoriasis.
    9. Arthritis in the same joint.
    10. Alcohol use during the study period or within 48 hours before the study enrolment.
    11. Patients judged unable to use the VAS for pain reliably
    12. Locally applied NSAID to the painful region/area of study or oral use of NSAID or other analgesics 48 hours before the study enrolment.
    13. Other pain killers than rescue medication to be taken during the study.
    14. Recurrent sprain at the same joint during the last 6 months.
    15. Anticoagulant therapy.
    16. Physiotherapy during study period.
    17. Open wounds, infected skin or fracture.
    18. Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the patient.
    19. Pregnant or lactating females.
    20. Participation in a drug or device study within 90 days before the study enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    • VAS pain score change over time from baseline (day 0 before treatment administration) to day 7
    E.5.1.1Timepoint(s) of evaluation of this end point
    Only measurements from the study visits (day 0, 3 and 7) will be included in the analysis.
    E.5.2Secondary end point(s)
    • Percentage VAS pain score change from baseline separately to day 3 and 7.
    • Area under VAS curve according to study visit measurements and patient diary from baseline separately to day 3 and 7 morning assessment.
    • Proportions of responders separately at day 3 and 7.
    • Time to reduction of 50% in pain score from baseline.
    • Proportion of patients who needed rescue medication during the study.
    • Change in VRS scores from baseline separately to day 3 and 7.
    - Functional impotence (absent, slight, moderate, severe).
    - Single leg load-bearing on the injured foot (possible without pain, possible with pain, impossible).
    - Assessment of pain (absent, slight, moderate, severe) by the investigator: pain at rest, pain under passive tension, pain under active tension, and pain on palpation.
    • Overall assessment of efficacy (excellent, good, poor) separately at day 3 and 7 by the patient.
    • Overall assessment of efficacy (excellent, good, poor) separately at day 3 and 7 by the investigator.
    • Change in peri-articular oedema (difference in perimeter between the injured and healthy ankle) over time from baseline to day 7.
    • The need for rescue medication.

    Tolerability assessments:
    • Condition of the skin (normal, abnormal) at day 0, 3 and 7
    • Overall assessment of tolerability by patient (excellent, good, acceptable, poor) at day 3 and 7
    • Overall assessment of tolerability by investigator (excellent, good, acceptable, poor) at day 3 and 7

    Safety assessments:
    • Physical examination including general and systemic examination and vital signs monitoring (blood pressure, heart rate and axillary temperature in sitting posture) will be done at day 0, 3 and 7.
    • Adverse event (AE) monitoring will be done at every visit. Patients will maintain a patient diary to record AEs and concomitant medications.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From day 0 to day 7
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 years
    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 months6
    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: 62
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    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)
    After end of the trial, the patient will be treated with the medical standard according to patients's need.
    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 Decision2011-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-05
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