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    Summary
    EudraCT Number:2011-005848-10
    Sponsor's Protocol Code Number:V00498TA201
    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:2012-07-18
    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 number2011-005848-10
    A.3Full title of the trial
    Analgesic profile of 3 new Ibuprofen lozenges (V0498TA01A 15mg, 25mg, 35mg) after single administration in acute sore throat pain
    Analgetisches Profil von 3 neuen Ibuprofen Lutschpastillen (V0498TA01A 15mg, 25mg, 35mg) nach Einzelgabe bei akuten Halsschmerzen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analgesic profile of 3 new Ibuprofen lozenges (V0498TA01A 15mg, 25mg,
    35mg) after single administration in acute sore throat pain
    Analgetisches Profil von 3 neuen Ibuprofen Lutschpastillen (V0498TA01A 15mg, 25mg, 35mg) nach Einzelgabe bei akuten Halsschmerzen
    A.4.1Sponsor's protocol code numberV00498TA201
    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 SponsorPIERRE FABRE MEDICAMENT
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointMyriam CONDOMINES
    B.5.3 Address:
    B.5.3.1Street Address3, avenue Hubert Curien
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number33534 50 62 09
    B.5.5Fax number33534 50 65 92
    B.5.6E-mailmyriam.condomines@pierre-fabre.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 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.3.2Product code V0498TA01A
    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 INNIBUPROFEN SODIUM DIHYDRATE
    D.3.9.1CAS number 31121-93-4
    D.3.9.4EV Substance CodeSUB21665
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.2
    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.IMP: 2
    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.3.2Product code V0498TA01A
    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 INNIBUPROFEN SODIUM DIHYDRATE
    D.3.9.1CAS number 31121-93-4
    D.3.9.4EV Substance CodeSUB21665
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32.0
    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.IMP: 3
    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.3.2Product code V0498TA01A
    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 INNIBUPROFEN SODIUM DIHYDRATE
    D.3.9.1CAS number 31121-93-4
    D.3.9.4EV Substance CodeSUB21665
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number44.8
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Strefen 8,75 mg, pastille
    D.2.1.1.2Name of the Marketing Authorisation holderReckitt Benckiser Healthcare France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameStrefen 8,75 mg, pastille
    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 INNFLURBIPROFEN
    D.3.9.1CAS number 5104-49-4
    D.3.9.4EV Substance CodeSUB07745MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.75
    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
    Akute Halsschmerzen
    E.1.1.1Medical condition in easily understood language
    Acute sore throat
    Akute Halsschmerzen
    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
    To compare the analgesic effect of Ibuprofen lozenges (V0498TA01A
    15mg, 25 mg, 35 mg) to placebo at 60 min after the start of sucking of
    study drug administered in single dose.
    E.2.2Secondary objectives of the trial
    - To compare the analgesic effect of Ibuprofen lozenges (V0498TA01A
    15mg, 25 mg, 35mg) to placebo at 30 min, 90 min, 120 min, 180 min,
    240 min, 300 min and 360 min after the start of sucking of study drug
    administered in single dose,
    - To compare the pain relief of Ibuprofen lozenges (V0498TA01A 15mg;
    25mg, 35mg) to placebo at 30 min, 60 min, 90 min, 120 min, 180 min,
    240min, 300 min and 360 min after the start of sucking of study drug
    administered in single dose,
    - To describe the analgesic effect and pain relief of the positive control:
    Strefen® at 30 min, 60 min, 90 min, 120 min, 180 min, 240min, 300 min
    and 360 min after the start of sucking of study drug administered in
    single dose,
    - To describe the safety of Ibuprofen lozenges
    (V0498TA01A15mg,25mg,35mg), placebo and positive control.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients 18 years and older.
    - patients with a sore throat associated or not with an URTI ≥ 24 hours and < or = 5 days duration, in the absence of Streptococcus group A. as confirmed by a swab test before randomisation
    - patients with tonsillopharyngitis ≥ 6 on 21-point TPA (Tonsillo Pharyngitis Assessment) scale.
    - patients with a Sore Throat Intensity Scale assessed by VAS more than or equal to 60 mm.
    - For female patients of child-bearing potential:
    - Negative urinary pregnancy test.
    - Use of an effective contraceptive method (oral contraception, surgical method, intra-uterine device or diaphragm) during the study and at least one week after the study end visit or
    - Agreements to have her male partner(s) use a condom during each
    sexual intercourse during the study and at least one week after the
    study end visit.
    - patients 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).
    - patients having signed a written informed consent.
    - patients affiliated to a social security system or are beneficiaries.
    E.4Principal exclusion criteria
    Related to pathologies
    - patients with pharyngeal paresthesia.
    - patients with pharyngeal mycosis.
    - patients with known peritonsillar abscess.
    - patients with hyposialia or asialia, any swallowing disorder.
    - patients with any painful condition that may have distracted attention from sore throat pain, (e.g. mouth ulcers).
    - patients with any disease that could compromise breathing such as bronchospasm or severe/instable asthma.
    - patients with evidence of mouth-breathing or uncomfortable coughing.
    - patients with a history of an upper gastrointestinal ulcer within the past 30 days, who are currently experiencing clinically significant upper gastrointestinal complaints, or are currently taking medication regularly (≥ 3 times in the previous week).
    - patients with Crohn's disease or ulcerative colitis.
    - patients with a severe renal impairment.
    - patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
    - patients with gastrointestinal bleeding or cerebrovascular hemorrhage or other hemorrhage.
    - patients with severe heart failure.
    - patients with severe hepatic failure.
    - patients with disseminated erythematous lupus.
    - patients with glucose and galactose malabsorption syndrom,fructose intolerance, or sucrase-isomaltase deficiency.

    Related to treatments
    - patients with known history of Ibuprofen or other NSAID-induced bronchospasm.
    - patients with a long term use of anti-inflammatory drugs.
    - patients with a long term use of anticoagulants or antiplatelet agents.
    - patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
    - patients having used analgesics within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
    - patients having used any long-acting or slow release analgesics within 12 hours before study entry (e.g. piroxicam or naproxen).
    - patients having used any anti inflammatory treatment within 12 hours before study entry.
    - patients having used any antiseptics 6 hours before study entry.
    - patients having used any local medication containing a local oral anaesthetic such as lozenge, spray, mouth rinse within 6 hours before study entry.
    - patients having used any topical throat treatment within 6 hours before
    study entry.
    - patients having taken antibiotics within 14 days before study entry.
    - patients having been treated with anticholinergic drugs, atropine, scopolamine, quaternary ammoniums, imipraminic antidepressives, phenothiazines neuroleptics, disopyramide, antimitotic drugs which influence salivary flow within 14 days before study entry.
    - patients with history of disgust for mint, peppermint, menthol.

    Related to population
    - patients with a history of alcohol abuse.
    - patients unable to refrain from smoking during their stay in the investigative site.
    - 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 nursing-mother
    - patient who is participating in or is in the exclusion period of another
    clinical trial
    - patients 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.
    - patients who has forfeited their freedom by administrative or legal award, or who is under guardianship.
    - patients who do not want to accept during the first 2H of the study, not
    to take other medications, suck other lozenges, use toothpaste, mouthwash, breath spray, smoke, use chew chewing gum, candies, eat or drink.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline of the Sore Throat Pain Intensity Scale (VAS) to 60
    min
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 min
    E.5.2Secondary end point(s)
    - Change from baseline of the sore throat pain intensity scale (VAS) to 30, 90, 120, 180, 240, 300 and 360 min.
    - TOTPAR0-30 , TOTPAR0-60 , TOTPAR0-90 , TOTPAR0-120 , TOTPAR0- 180, , TOTPAR0-240 , TOTPAR0-300 and TOTPAR0-360 (calculated as Area Under the Curve (AUC) of the Total Pain Relief).
    - SPID norm 0-30, SPID norm 0-60, SPID norm0-90, SPID norm0-120, SPID norm0-180, SPID norm0-240 SPID norm0-300 and SPID norm0- 360 (representing the time-weighted average relief over the selected period).
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 min, 60 min, 90 min, 120 min, 180 min, 240 min, 300 min, 360 min
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3.1Comparator description
    Strefen; positive control
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    The end of study is the date of the phone call for the last patient
    undergoing the trial.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 185
    F.4.2.2In the whole clinical trial 185
    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 Decision2012-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-02
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