Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44306   clinical trials with a EudraCT protocol, of which   7355   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-000242-35
    Sponsor's Protocol Code Number:18CT0003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-02-28
    Trial 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 number2019-000242-35
    A.3Full title of the trial
    Randomized, double blind, double dummy, parallel-groups, clinical trial on efficacy and safety of ibuprofen/N-acetylcysteine fixed dose combination vs. individual components (ibuprofen and N-acetylcysteine monotherapy) in patients with symptomatic noncomplicated upper respiratory tract infections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial on efficacy and safety of ibuprofen/N-acetylcysteine fixed dose combination vs. individual components (ibuprofen and Nacetylcysteine monotherapy) in patients with symptomatic noncomplicated upper respiratory tract infections
    A.4.1Sponsor's protocol code number18CT0003
    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 SponsorE-Pharma Trento SpA
    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 supportE-Pharma Trento S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPhidealive S.r.l.
    B.5.2Functional name of contact pointClinical Trial Unit
    B.5.3 Address:
    B.5.3.1Street Addressvia Ludovico di Breme, 9
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number+3902450531
    B.5.5Fax number+390245053505
    B.5.6E-mailricercaclinica@phidealive.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.3.1Product nameIbuprofen 400 mg and N-Acetylcysteine 200 mg
    D.3.2Product code IBU-NAC
    D.3.4Pharmaceutical form Granules for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 Moment Act® analgesico granulare
    D.2.1.1.2Name of the Marketing Authorisation holderAziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A. - Viale Amelia, 70 - 00181 Roma
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    D.3.4Pharmaceutical form Granules for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 Naxil
    D.2.1.1.2Name of the Marketing Authorisation holderBELUPO Medicines and Cosmetics Ltd. Danica 5 Street 48 000 Koprivnica – Croazia
    D.2.1.2Country which granted the Marketing AuthorisationCroatia
    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 nameN-Acetylcysteine
    D.3.4Pharmaceutical form Effervescent tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboGranules for oral solution
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEffervescent tablet
    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
    symptomatic non-complicated upper respiratory tract infections
    E.1.1.1Medical condition in easily understood language
    symptomatic non-complicated upper respiratory tract infections
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10046309
    E.1.2Term Upper respiratory tract infections
    E.1.2System Organ Class 100000004862
    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 this study is to compare the efficacy of
    ibuprofen/N-acetylcysteine fixed dose combination (FDC) over the
    reference ibuprofen monotherapy and N-acetylcysteine monotherapy in
    the time to resolution of symptoms of upper respiratory tract infection
    (URTI), defined as absence of fever and a score = 0 of each individual
    symptom on a 0-4 Likert rating scale.
    E.2.2Secondary objectives of the trial
    to evaluate:
    -The overall clinical efficacy (cure/improvement/failure) of
    ibuprofen/N-acetylcysteine FDC in comparison with individual
    components ibuprofen and N-acetylcysteine;
    -The efficacy of ibuprofen/N-acetylcysteine FDC on individual signs and
    symptoms of URTI in comparison with individual components ibuprofen
    and N-acetylcysteine;
    -The efficacy of ibuprofen/N-acetylcysteine FDC in the proportion of
    patients with resolution of symptoms of URTI in comparison with
    individual components ibuprofen and N-acetylcysteine;
    -The efficacy of ibuprofen/N-acetylcysteine FDC on cold symptoms, as
    evaluated with the Wisconsin Upper Respiratory Symptoms Survey
    (WURSS-11), in comparison with individual components ibuprofen and
    N-acetylcysteine;
    -The efficacy of ibuprofen/N-acetylcysteine FDC in the patient's
    perception of the severity of symptoms, in comparison with individual
    components ibuprofen and N-acetylcysteine;
    -The safety of the investigational study drugs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients, age range 18-65 years (included);
    2. Body mass index (BMI) within the range of 18.5 to 30 kg/m2
    3. Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 20 cigarettes per day for 1 year)
    4. Patients willing to sign the Informed consent and available to fulfil all
    tasks and visits foreseen by the protocol;
    5. Patient with symptoms of non-complicated URTI (e.g. fever, cold
    symptoms, productive cough, sore throat, shortness of breath and
    limitation in daily activities) for ≤ 7 days, without signs of disease in the
    lower respiratory tract on physical examination;
    6. Presence of productive cough of at least moderate intensity (i.e. a
    score ≥ 2 on a 0-4 point Likert scale) and at least one of the following
    conditions: fever ≥ 37,5 °C and/or any signs and symptom of noncomplicated
    URTI (fever, cold symptoms, sore throat, shortness of
    breath and limitation in daily activities) of at least moderate intensity
    (i.e. a score ≥ 2 on a 0-4 point Likert scale);
    7. Good general health as determined by the Investigator based on
    medical history and physical examination;
    8. Female of child-bearing potential (i.e. not in menopausal status from
    at least one year or permanently sterilized) must have a negative urine
    pregnancy test prior the first investigational medicinal product (IMP)
    administration.
    E.4Principal exclusion criteria
    1. Patients with asthma or chronic obstructive pulmonary disease
    (COPD) or other chronic respiratory disorders;
    2. Patients with suspected lower respiratory tract infection or other
    infections requiring treatment with antibiotics;
    3. Pregnancy or lactation period throughout the whole study duration;
    4. If female and of child-bearing potential, patient not using a highly
    effective method of birth control. Highly effective birth control methods
    include: combined hormonal contraception (containing oestrogen and
    progestogen) associated with inhibition of ovulation (oral, intravaginal,
    transdermal); progestogen-only hormonal contraception associated with
    inhibition of ovulation (oral, injectable, implantable); intrauterine device
    (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal
    occlusion; vasectomised partner; sexual abstinence*;
    5. History of allergy or hypersensitivity or intolerance to ibuprofen
    and/or N-acetylcysteine and/or to any excipients of study drugs;
    6. Known hypersensitivity to non-steroidal anti-inflammatory drugs;
    7. Use of antipyretics in the 12 hours before Visit 1;
    8. Use of non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics
    in the week before Visit 1, inhaled or oral corticosteroids within 2 weeks
    or intravenous corticosteroids within 4 weeks before Visit 1;
    9. Use of antibiotics in the week before Visit 1;
    10. Use of bronchodilators in the week before Visit 1;
    11. Use of leukotriene antagonists in the week before Visit 1;
    12. Patients with clinical signs of or known gastro-duodenal ulcer;
    13. Patients with clinical signs or history of coagulation disorders, or
    with a history of recurrence ulceration or gastrointestinal bleeding;
    14. Systolic blood pressure outside the range of 100 to 140 mmHg
    and/or diastolic blood pressure outside the range of 60 to 90 mmHg with
    clinical relevance;
    15. Heart rate outside the range of 50 to 90 beats/min with clinical
    relevance;
    16. Clinically significant or unstable concurrent diseases whose
    sequeleae or treatment might contraindicate study participation or
    interfere with the study evaluation parameters;
    17. History of drug abuse or use of illegal drugs: use of soft drugs, e.g.
    marihuana within 6 months of screening or hard drugs, e.g. cocaine,
    amphetamines, phencyclidine within 1 year of screening;
    18. Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol
    equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered
    alcoholics;
    19. Patient with a history of serious psychiatric disorders;
    20. Anticipated poor compliance by the patient;
    21. Previous participation in this clinical study;
    22. Participation in another clinical trial at same time or within the
    preceding 180 days (calculated from the date of the final examination of
    the previous study).
    E.5 End points
    E.5.1Primary end point(s)
    Time to resolution of symptoms of URTI, defined as absence of fever and a score = 0 of each individual sign and symptom (productive cough, fever, cold symptoms, sore throat, shortness of breath and limitation in daily activities) on a 0-4 Likert rating scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2 or early termination visit. If patients terminate early before Visit
    2,
    Visit 2 should be arranged and procedures will be those scheduled for
    Visit 2/early termination visit
    E.5.2Secondary end point(s)
    -Investigator's overall assessment of efficacy: cure (complete
    disappearance of signs and symptoms of inflammation), improvement
    (non-complete resolution of signs and symptoms of inflammation),
    failure (persistency or worsening of signs and symptoms of
    inflammation);
    -Change from baseline of fever, and of total score and score of individual
    signs and symptoms of URTI (productive cough, cold symptoms, sore
    throat, shortness of breath and limitation in daily activities), evaluated
    by patients on a 0-4 point Likert scale (0 = no symptom; 1 = mild
    symptom; 2 = moderate symptom; 3 = severe symptom; 4 = very severe
    symptom) using a daily diary. Changes from baseline will be evaluated
    as score and area under the curve (AUC) of individual signs and
    symptoms of URTI;
    -Proportion of patients with resolution of symptoms, defined as absence
    of fever and a score = 0 of each individual signs and symptom of URTI;
    -Changes from baseline on total score and single items of the Wisconsin
    Upper Respiratory Symptoms Survey (WURSS-11);
    -Changes from baseline in the patient's perception of the severity of
    symptoms of URTI, as evaluated by means of a 100 mm visual analogue
    scale (VAS);
    -Global assessment of efficacy by patient, performed at the end of
    treatment (Day 7 ± 1), and at the end of the follow up period by
    phone(Day 14 ± 2), by means of a 0-4 point Likert scale (0 = poor; 1 =
    slight; 2 = moderate 3 = good; 4 = excellent). The end of treatment may
    be anticipated at any time prior to Day 7 ± 1 for symptom resolution or
    safety reasons. In such cases, the overall patient efficacy assessment
    will be maintained on Day +7 ± 2 after the interruption.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2 or early termination visit. If patients terminate early before Visit
    2,
    Visit 2 should be arranged and procedures will be those scheduled for
    Visit 2/early termination visit
    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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ibuprofen +placebo; N-acetylcysteine +placebo
    E.8.2.4Number of treatment arms in the trial3
    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 concerned30
    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 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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 350
    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 state350
    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)
    No treatment is required at the end of the study and, if necessary,
    patients will be treated according to current medical practice.
    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 Decision
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-12-07
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA