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   43861   clinical trials with a EudraCT protocol, of which   7284   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:2007-002995-33
    Sponsor's Protocol Code Number:MU-707 901
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-07-31
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-002995-33
    A.3Full title of the trial
    Efficacy and safety of three dosages of Wobenzym mono in patients with acute rhinosinusitis
    Randomised, comparative, parallell group, placebo controlled, double-blind, multicentre, two phase adaptive study
    A.4.1Sponsor's protocol code numberMU-707 901
    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 SponsorMUCOS Pharma GmbH Co. KG
    B.1.3.4CountryGermany
    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 Wobenzym mono
    D.2.1.1.2Name of the Marketing Authorisation holderMUCOS Pharma GmbH & Co.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namenot applicable
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Gastro-resistant 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 INNBromelain
    D.3.9.1CAS number 9001-00-7
    D.3.9.2Current sponsor codenone
    D.3.9.3Other descriptive namenone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number133 to 178
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 Yes
    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 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
    Acute rhinosinusitis:
    with a rhinsinusitis symptom score >= 13 points (of maximal 25 points) using a 6 point-rating scala for the following symptoms which arose within up to 3 days prior to visit 1:
    Facial pain or pressure
    Anterior or posterior discharge or both
    Nasal congestion
    Reduced productivity
    Wake up at night
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052106
    E.1.2Term Rhinosinusitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of a 14 days treatment with the pineapple enzyme preparation Wobenzym mono using three different dosages compared to placebo for the treatment of acute rhinosinusitis on the basis of 5 main rhinosinusitis symptoms assessed twice daily by the patient.
    E.2.2Secondary objectives of the trial
    ·To determine the optimal dose with the best efficacy.
    ·To assess the safety of Wobenzym mono compared to placebo applied in patients with acute rhinosinusitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have given their signed declaration of consent and data protection declaration
    2. Males and females at the age of 18 – 70 years
    3. Patients with a diagnosis of acute rhinosinusitis
    ·characterised by a rhinosinusitis symptom sum score ≥ 13 points (minimum 0, maximum 25 points) using a 6-point rating scale for the following symptoms which arose within up to 3 days prior to visit 1:
    At visit 1 the patient will assess the rhinosinusitis symptoms for Day -1 in the evening (retrospectively) and for Day 0 in the morning. The rhinosinusitis symptom sum score is the sum of the mean scores each for

    - Facial pain or pressure sensation (Day -1, evening / Day 0, morning)*
    - Anterior or posterior discharge or both (Day -1, evening / Day 0, morning)*
    - Nasal congestion (Day -1, evening / Day 0, morning)*
    plus score for
    - Reduced productivity (Day -1, evening)
    - Wake up during night (Day 0, morning)
    and evaluated by ultrasonography of paranasal sinuses.
    * At least two of these 3 symptoms must be of at least moderate severity (score ≥ 3).
    E.4Principal exclusion criteria
    Medical history and medications
    1. Chronic rhinosinusitis with or without nasal polyps
    2. Acute exacerbation of a chronic rhinosinusitis
    3. History of surgery of paranasal sinuses
    4. History or presence of type 1 allergy (e.g. allergic rhinitis, allergic conjunctivitis, allergic bronchial asthma)
    5. Non-allergic perennial rhinitis
    6. Known intolerance against drug substance and / or excipient of the tablets (especially pineapple, lactose)
    7. Pregnancy and /or lactation period
    8. Current or participation in a clinical trial less than 30 days ago or participation in the same trial
    9. Previous and concomitant medication like systemic, inhaled or nasal corticosteroids (beginning 4 weeks prior to visit 1), antibiotics, antihistamines, phytotherapeuticals and others for upper airway diseases incl. α-adrenergic agonists (beginning 7 day prior to visit 1)
    10. Hemorrhagic diathesis
    11. Concomitant medication likely to increase risk of bleeding (e.g. anticoagulants, platelet aggregation inhibitors)
    12. History of palpitations
    13. Severe diseases of liver or kidney; immunodeficiency, mucoviscidosis, asthma
    14. Severe somatopathic, neurological and / or psychiatric diseases
    15. Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse)
    16. History of alcohol and / or drug of abuse

    General
    17. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
    18. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
    19. Patients in custody by juridical or official order
    20. Evidence of an uncooperative attitude (non-compliance)
    21. Patients who have difficulties in understanding the language in which the patient information is given
    22. Patients who do not agree to the transmission of their pseudonymous data within the liability of documentation and notification
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    Time to relevant (50%) improvement of the rhinosinusitis symptom sum score. Each of the 5 individual symptoms will be rated in the diary by a 6-point rating scale.
    Due to a possible undulant course of the morning and evening sum score from day to day, the rhinosinusitis symptom sum score will be calculated using the scores of the morning and evening assessment in the following way:
    Mean scores of evening and subsequent morning assessment each for
    - Facial pain or pressure sensation
    - Anterior or posterior discharge or both
    - Nasal congestion
    plus score of evening assessment for
    - Reduced productivity
    plus score of subsequent morning assessment for
    - Wake up during night

    According to this procedure the baseline value of the rhinosinusitis symptoms sum score will be calculated from the assessments of Day -1 in the evening (retrospectively) and Day 0 in the morning (office assessments).
    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 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) 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.8.4.1Number 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 will be mith of April 2008 at last patient out of alltogether 468 enrolled patients
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.1In 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 Yes
    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 2007-07-31. Yes
    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 state468
    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)
    Patients who are not cured by visit 3 and who need further drug treatment for acute rhinosinusitis will receive a medication available on the market as prescríbed by the investigator.
    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 Decision2007-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-11-16
    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-Fri Apr 26 07:33:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA