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    The EU Clinical Trials Register currently displays   39211   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-000058-35
    Sponsor's Protocol Code Number:A7801002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-000058-35
    A.3Full title of the trial
    A community pharmacy based investigation in the self-medication area

    Efficacy and safety of Sinutab® [Paracetamol (500mg) and Pseudoephedrine (30mg)] on subjects with nasal congestion accompanied by headache in the setting of a common cold
    A.4.1Sponsor's protocol code numberA7801002
    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 SponsorPfizer Consumer Healthcare Comm. VA/SCA
    B.1.3.4CountryBelgium
    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.2.5The 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 nameSinutab 500/30mg tablets
    D.3.4Pharmaceutical form Tablet
    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 INNparacetamol
    D.3.9.1CAS number 103-90-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpseudoephedrine
    D.3.9.1CAS number 345-78-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The medical rationale = to investigate this combination drug in the symptomatic relief of common cold with nasal symptoms. The reduction of symptom severity may allow subjects receiving active medication to return to work or school earlier than those receiving placebo.

    To study the drug in it’s ‘natural environment’, community pharmacists will function as local investigators. They will include subjects with early (≤ 48 hours) cold symptoms of blocked nose with headache.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effectiveness of Sinutab on the symptom relief of nasal congestion and headache in the setting of a common cold.
    E.2.2Secondary objectives of the trial
    1. To assess the effectiveness of Sinutab on the major symptom complex (MSC) of common cold which consists of 4 signs/symptoms: nasal congestion, headache, sore throat, and pressure around the eyes
    2. To assess the effectiveness of Sinutab on the symptom relief of individual sign/symptoms, including nasal congestion, headache, sore throat, and pressure around the eyes
    3. To assess the number of days lost at work or school
    4. To assess the effect of Sinutab on the quality of life (day/night)
    5. To assess time-to-resolution of common cold
    6. Overall safety evaluation
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Only subjects asking for Sinutab® in the pharmacy can participate in the study. These subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Age 18 years or more
    2. Reported cold symptoms begin ≤ 48 hours prior to visit 1
    3. Scored > or = 2 for each of nasal congestion and headache using the Modified Jackson Subject Evaluation Scale
    4. Willing and able to comply with scheduled visits, treatment plan, and other study procedures
    5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
    E.4Principal exclusion criteria
    1. Patients without an electronic medication record in the pharmacy
    2. Have a history of hypersensitivity to paracetamol or pseudoephedrine or lactose
    3. Have a fever more than 38.0°C (measured by pharmacist)
    4. Women in the fertile years who do not practise a hormonal contraception or an intra-uterine device
    5. Use of concomitant drugs that could interfere with the study drug; See concomitant medication Questionnaire.
    Not allowed is current use (nasal, oral or inhalation) of:
    Analgesics
    Antipyretics
    Cough medicines
    Antihistaminics
    Corticosteroids
    Metformine
    Sympathomimetics and
    Anticholinergic drugs
    Not allowed is current or past (≤ 2 weeks) use of:
    Monoamine oxidase inhibitors
    Antibiotics
    6. Any important intercurrent medical condition will be excluded based on the available medication record of the patient. (cf. exclusion criterium 1)
    6.1. Bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD) will be excluded by the use of sympathomimetics, anticholinergics, theofylline and derivatives, inhalation steroids, inhibitors of mediator release, leukotriene receptor antagonists, Dopram®, Alvofact® or Survanta®; Allergies will be excluded by the use of treatment for desensitization to household or seasonal allergies, such as Pollinex® or individually tailored preparations. Excepted are: (1) non-active seasonal allergies, (2) drug allergies other than paracetamol and pseudoephedrine (cf. 1), and (3) food allergies.
    6.2. Subjects using antihypertensive treatment: diuretics, β-blockers, calcium antagonists, angiotensine conversion enzyme inhibitors, angiotensine-II-receptor antagonists, vasodilatation drugs, α-blockers or centrally acting antihypertensives. History of nasal reconstructive surgery.
    6.3. Any male subjects taking medication for treatment of Benign Prostate Hypertrophy (BPH): α1-blockers, 5-alpha-reductase-inhibitors or phytotherapy based on Serenoa repens.
    6.4. A history of alcohol and/or drug abuse within a 6-month period immediately preceding the screening visit.
    6.5. Use of medication for treatment of cardiovascular conditions other than hypertension: drugs for treatment of heart failure, antianginal drugs, antiarrhythmics or Omacor®.
    6.6. Use of medication for treatment of cholelithiasis (urodesoxychol acid), and drugs used for a whole spectrum of symptoms in the hepatobiliary scope, including Cantabiline®, Hebucol®, Vibtil® and relatives.
    6.7. Use of antitumour agents.
    6.8. Use of tuberculostatics or antiviral medicines (e.g. HIV).
    6.9. The use of tricyclic antidepressants (TCA’s), Trazodone® or antipsychotics: fenothiazine, thioxanthene, butyrofenone, difenylpiperidine, benzamine or atypical neuroleptics.
    Any such medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the sub-investigator, would make the subject inappropriate for entry into this study.
    7. Participation in other clinical trials the last three months and during study participation.
    8. Employees of the clinical research centers Pfizer, the CRO’s contracted for this study, or their immediate family members are not permitted to participate in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the sum of nasal congestion and headache sign/symptom scores during the treatment period. The nasal congestion and headache scores will be summed by day; the daily sums will be averaged over the treatment days; and the change from the baseline will be calculated.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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
    End of Trial in all Participating Pharmacies is defined when data from 300 evaluable subjects are collected and verified.
    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
    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) Yes
    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 2006-04-14. 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 state500
    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 Decision2006-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-25
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