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    The EU Clinical Trials Register currently displays   37485   clinical trials with a EudraCT protocol, of which   6150   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-001720-36
    Sponsor's Protocol Code Number:BAY E 4465/11764
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-001720-36
    A.3Full title of the trial
    A pivotal, placebo controlled, phaseIII study to compare efficacy and tollerability of a fixed combination, containing 500 mg ASA and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.
    A.4.1Sponsor's protocol code numberBAY E 4465/11764
    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 SponsorBAYER
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name Aspirin Complex
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare AG
    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 Granules
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNacetylsalicyclic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpseudoephedrine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.3.11.13.1Other medicinal product typeAntiinflammatory
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cold related pain/fever e.g. sore throat, headache, ear eache, sinus pressure and nasal congestion.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10028735
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    verificare la superiorita' della combinazione fissa di ASA 500 mg e PE 30 mg in confronto al solo ASA 500 mg(granuli, 2 bustine) nella congestione nasale nonche la superiorita' della stessa combinazione alla stessa dose in confronto alla sola PE 30 mg (granuli, 2 bustine) nel dolore di gola.

    E.2.2Secondary objectives of the trial
    1)Safety e tollerabilita' 2) differenze nell'intensita' di dolore verso il basale a vari tempi fino a tre giorni dopo la prima dose 3)Scomparsa del dolore totale verso il basale a vari tempi fino a tre giorni dopo la prima dose
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Male and female patients between 18-65 years of age
    • Onset of cold symptoms within the previous 96 hours (4 days)
    • Current complaint of at least moderate sore throat baseline, confirmed by a score ≥ 6 on the sore throat pain scale (numerical 0 - 10 scale)
    • Current complaint of at least moderate nasal congestion at baseline, confirmed by a score ≥ 6 on the nasal congestion scale (numerical 0 – 10 scale)
    • History of other symptoms associated with upper respiratory tract infection (URTI) in the past 4 days
    • Other findings of upper respiratory tract infection, confirmed on the physical examination
    • Agree to comply with the study requirements
    • Written informed consent prior to enrollment in the study
    E.4Principal exclusion criteria
    Patients must not have one or more of the following conditions:
    • Pregnant or lactating females
    • Uncontrolled chronic diseases
    • History of hypersensitivity (allergic reaction) to ASA, any other NSAID or PE
    • Any disease which significantly compromises breathing or interferes with the patients assessment of sore throat
    • History of -, or active peptic ulcer
    • Severe impaired hepatic function
    • Severe impaired renal function
    • Severe not compensated heart insufficiency
    • Severe hypertension
    • Severe coronary heart disease
    • Simultaneous intake of monoamino-oxidase inhibitors
    • Use of menthol-containing tissues within the previous 2 hours
    • Taking of any menthol-containing product within previous 4 hours
    • Use of any local or systemic short-acting cough and cold preparations in the past 6 hours
    • Use of any local or systemic long-acting cough and cold preparations in the past 12 hours
    • Any analgesic within previous 12 hours
    • Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection
    • Currently taking or had taken anticoagulants, corticoids, NSAIDs, methotrexate or lithium
    • Taken part in another clinical trial within the last 30 days
    • Already participated in this study
    • Any significant disease or condition which, in the investigators opinion, may interfere with the study objectives
    E.5 End points
    E.5.1Primary end point(s)
    1) congestione nasale: area sotto la curva calcolata sui punteggi corretti per i valori basali di congestione nasale(NCS) nelle due ore iniziali dopo la somministrazione (AUC-NCS 2ore) 2) dolore di gola: SPID 2 ore, inteso come la somma delle differenze di intensita' del dolore nelle 2 ore iniziali dell'osservazione

    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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.1.3Elderly (>=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 2006-08-03. 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 state510
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1010
    F.4.2.2In the whole clinical trial 1010
    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 Decision2005-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-14
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