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    The EU Clinical Trials Register currently displays   42567   clinical trials with a EudraCT protocol, of which   7008   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2012-004423-20
    Sponsor's Protocol Code Number:V00498TA301
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-004423-20
    A.3Full title of the trial
    STUDY OF EFFICACY AND SAFETY OF V0498 VERSUS PLACEBO IN ACUTE SORE THROAT PAIN
    Multicenter, randomised, placebo-control parallel groups study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ibuprofen lozenge for Pain in Acute Sore Throats
    A.3.2Name or abbreviated title of the trial where available
    Ibuprofen lozenge in acute sore throat pain
    A.4.1Sponsor's protocol code numberV00498TA301
    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 SponsorCentre de Recherche et Développement Pierre Fabre
    B.1.3.4CountryFrance
    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 organisationCPS Research
    B.5.2Functional name of contact pointDr GM Crawford
    B.5.3 Address:
    B.5.3.1Street Address3 Todd Campus
    B.5.3.2Town/ cityWest of Scotland Science Park
    B.5.3.3Post codeG20 0XA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0141 946 7888
    B.5.5Fax number0141 946 1324
    B.5.6E-mailgordon@cpsresearch.co.uk
    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 nameIbuprofen lozenge
    D.3.2Product code V0498 lozenge
    D.3.4Pharmaceutical form Lozenge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Ibuprofen dihydrate
    D.3.9.1CAS number 31121-93-4
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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 placeboLozenge
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Sore Throat Pain
    E.1.1.1Medical condition in easily understood language
    Acute Sore Throat Pain
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10049140
    E.1.2Term Pharyngotonsillitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 compare the analgesic effect of V0498 lozenges versus placebo on the Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered
    E.2.2Secondary objectives of the trial
    To compare the analgesic effect of V0498 ibuprofen lozenges versus placebo with the following assessments:

    •on the Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 15min, 30 min, 45min, 60 min, 90 min after the start of sucking of the 1st study drug administered,.

    •on the Sore Throat Pain Intensity Difference (PID) on swallowing from baseline to 30min, 60min, 90min after the start of sucking of the 1st study drug administered, D1 evening, D2, D3 and D4.

    •on the Sum of Pain Intensity Differences on swallowing (SPID) from baseline to 30min, 60min, 90min, 120min after the start of sucking of the 1st study drug administered

    •on the pain responders rate (reduction of 50% of baseline score) 30min, 60min, 90min,120min after the start of sucking of the 1st study drug administered, D1 evening, D2, D3 and D4

    •on the time of onset of the first pain response within the 120min after the start of sucking of the 1st study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - male or female aged at least 18 years old
    - patient with an acute sore throat:
    - of recent onset (within the last 72 hours)
    - associated or not with an upper respiratory tract infection (URTI)
    - in the absence of Streptococcus group A (negative Streptococcal swab test before randomisation)
    - Tonsillo-Pharyngitis Assessment scale (TPA) ≥ 5 on a 21- point scale
    - Sore Throat Pain Intensity when swallowing (STPIS) ≥ 60 mm on a 100 mm visual analogue scale (VAS)
    - for female patient with child-bearing potential: negative urinary pregnancy test
    - patient able to understand and to comply with all study procedures (e.g. such as those who could understand correctly the use of the pain rating scales)
    - patient having signed a written informed consent

    E.4Principal exclusion criteria
    Related to pathologies:
    - severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
    - oro-pharyngeal paresthesia or mycosis
    - severely traumatised and/or very severe oromucosal inflammation
    - tonsillopharyngectomy
    - Peritonsillar abscess
    - hyposalivation or asialia, or any swallowing disorder other than linked to sore throat.
    - any painful condition that may have distracted attention from sore throat pain, (e.g. mouth ulcers)
    - any disease that could compromise breathing such as bronchospasm or severe/instable asthma
    - mouth-breathing or uncomfortable coughing
    - history of an upper gastrointestinal ulcer within the past 30 days before randomisation
    - Crohn’s disease or ulcerative colitis
    - history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
    - known cerebrovascular haemorrhage or other haemorrhage disease
    - severe heart failure
    - severe renal impairment
    - severe hepatic failure
    - disseminated erythematous lupus

    Related to treatments:
    - hypersensitivity to ibuprofen or other NSAIDs (including bronchospasm) or to excipients
    - long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of anti-inflammatory drugs
    - any long-acting or slow release analgesic intake including NSAIDs within 24 hours before randomisation (e.g. piroxicam or naproxen)
    - any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
    - any paracetamol intake within 6 hours before randomisation
    - any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
    - any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
    - any product with demulcent properties within 2 hours before randomisation
    - any antibiotics intake by systemic route within 7 days before randomisation
    - any intake of anticoagulants or antiplatelet agents within 14 days before randomisation
    - any intake of anticholinergic drugs, atropine, scopolamine, quaternary ammoniums, imipraminic antidepressives, phenothiazines, neuroleptics, disopyramide or antimitotic drugs which influence salivary flow within 14 days before randomisation

    Related to population:
    - heavy smokers (>20 cigarettes/day)
    - history of alcohol abuse
    - patient who is a family member or work associate (secretary, nurse, technician ..) of the investigator
    - female patient who is in post-partum period or a breast-feeding mother
    - patient who is participating in or is in the exclusion period of another clinical trial
    - patient mentally unable in the opinion of the investigator to understand the nature and the objectives of the study and unable to comply fully with the study requirements
    - patient who has forfeited his freedom by administrative or legal award, or who is under guardianship
    - patient who does not accept not to take any medications or OTC drugs during the 1 hour before and the 2 hours after the start of sucking of the 1st study drug administered
    - patient who does not accept not to eat or not to drink or not to smoke during the 1 hour before and the 2 hours after the start of sucking of the 1st study drug administered
    - patient who does not accept not to smoke or not to eat or not to drink at least 1 hour before each assessment timepoint
    - pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure of the study is to compare the effect of V0498 lozenges to that of placebo on the Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to 120 minutes
    E.5.2Secondary end point(s)
    1-TOTal PAin Relief (TOTPAR)
    2-Sore Throat Pain Intensity Difference (PID) on swallowing
    3-Sum of Pain Intensity Differences on swallowing (SPID)
    4-Pain responders rate
    5-Time of onset of the first pain response within 120 min
    6-Time of onset of the first pain relief within 120 min
    7-Global efficacy rating by the patient
    8-Investigator’s overall assessment
    9-Lozenges consumption
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-over 15min, 30 min, 45min, 60 min, 90 min after the start of sucking of the 1st study drug administered.
    2-from baseline to 30 min, 60 min, 90 min after the start of sucking of the 1st study drug administered, Day 1 evening, Day 2, Day 3 and Day 4
    3-from baseline to 30min, 60 min, 90 min,120min after the start of sucking of the 1st study drug administered
    4-at 30 min, 60 min, 90 min, 120 min after the start of sucking of the 1st study drug administered, D1 evening, D2, D3 and D4
    5-Time of onset of the first pain response within the 120 min
    6-Time of onset of the first pain relief within the 120 min
    7-At 120 min and D1 evening, D2, D3 and D4
    8-At 120 min and during the study-end visit (D5)
    9-By calendar day from D1 to D4

    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 months9
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 122
    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 No
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 382
    F.4.2.2In the whole clinical trial 382
    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)
    On completion of the study, patients will revert to taking suitable OTC medications or other treatment prescribed by their GP as appropriate.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-20
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