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    Summary
    EudraCT Number:2013-004977-28
    Sponsor's Protocol Code Number:701079.01.013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-004977-28
    A.3Full title of the trial
    Safety and intake effect of EPs®7630 (an extract from the roots of Pelargonium sidoides)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and intake effect of EPs®7630 (an extract from the roots of Pelargonium sidoides)
    A.4.1Sponsor's protocol code number701079.01.013
    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 SponsorDr. Willmar Schwabe 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 supportDr. Willmar Schwabe GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Willmar Schwabe GmbH & Co. KG
    B.5.2Functional name of contact pointProject Leader
    B.5.3 Address:
    B.5.3.1Street AddressWillmar-Schwabe-Str. 4
    B.5.3.2Town/ cityKarlsruhe
    B.5.3.3Post code76227
    B.5.3.4CountryGermany
    B.5.4Telephone number00497214005635
    B.5.5Fax number004972140058635
    B.5.6E-mailjuliette.brandes@schwabe.de
    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 Kaloba Pelargonium Cough & Cold Relief tablets
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEPs®7630
    D.3.2Product code EPs®7630
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNEPs® 7630
    D.3.9.2Current sponsor codeEPs® 7630
    D.3.9.3Other descriptive namePELARGONIUM ROOT LIQUID EXTRACT, DRIED
    D.3.9.4EV Substance CodeSUB47684
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 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 placeboFilm-coated 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
    common cold
    E.1.1.1Medical condition in easily understood language
    common cold
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10010106
    E.1.2Term Common cold
    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
    To investigate the safety of a long-term (4 months) treatment with EPs®7630
    E.2.2Secondary objectives of the trial
    To analyse the health status of the participants during the study course.
    To analyse protective effects of the IMP against common cold occurrence.
    To analyse the effect of the IMP during a cold episode.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Adult male or female participant (≥ 18 years old)
    (2) Participant provided a written informed consent in accordance with the legal requirements
    (3) Participant with willingness and ability to comply with all procedures of the clinical trial and be available for the duration of the study
    (4) Participant is of good physical and mental condition
    (5) Participant experienced ≥ 2 colds per year in the last 12 months
    E.4Principal exclusion criteria
    (1) Chronic respiratory tract or lung disease (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer)
    (2) History of heart, renal, liver, neuromuscular disease and/or immunosuppression
    (3) Known allergic bronchial asthma
    (4) Known or suspected congenital anomalies of heart, kidney, liver, or mental disabilities
    (5) Participant with concomitant medications that might impair the interpretation of trial results (e.g. herbal medications for common cold other than the investigational product, or pain relief medications other than Paracetamol or Ibuprofen)
    (6) Women of child-bearing potential with no adequate and effective contraception:
    - Established use of oral, injected or implanted hormonal methods of contraception
    - Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    - Barrier methods of contraception: Condom and/or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    - Sexual abstinence
    - Vasectomised partner
    (7) Female participant who is pregnant, lactating or planning pregnancy during the course of the clinical trial
    (8) Participant with cold symptoms at inclusion
    (9) Current intake of antimicrobial and/or antiviral medication for any reason
    (10) Participant with known or suspected history of alcohol or drug abuse
    (11) Heavy smoking (> 10 cigarettes per day)
    (12) Psychiatric disorders which may influence the results of the trial, epilepsy, or suicide attempts
    (13) Planned surgical intervention during the trial
    (14) Known gastrointestinal disorders with uncertain absorption of orally administered medication (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, disbacteriosis) or associated with diarrhoea
    (15) Known or suspected hypersensitivity to the active substance or to any of the excipients of the investigational product
    (16) Known clinically relevant laboratory abnormalities
    (17) Participant with increased tendency to bleed, especially nasal or gingival bleeding
    (18) Previous (within the last 3 months prior to visit 1) or concomitant treatment with coagulation-inhibiting drugs such as warfarin
    (19) Participation in a further clinical trial at the same time or within the last 4 weeks prior to inclusion into the present study
    (20) Previous randomisation in the present clinical study
    (21) Irresponsible subjects or those unable to understand nature, meaning and consequences of the trial
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of Adverse Drug Reactions (ADRs) during the 4 months treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Suspected ADRs will be documented during the whole treatment period.
    E.5.2Secondary end point(s)
    A) Occurrence of Adverse Events (AEs) during the 4 months treatment
    B) Protective effects
    C) Effects during a cold episode
    E.5.2.1Timepoint(s) of evaluation of this end point
    A) Adverse events will be documented during the whole treatment period.
    B) Protective effects will be evaluated during the whole treatment period.
    C) Treatment effects on cold symptoms will be documented for 14 days after onset of first cold symptom.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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.8.2.4Number of treatment arms in the trial3
    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 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
    End of trial is defined as date of report synopsis: January 2016
    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 months11
    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: 650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state720
    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 Decision2014-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-31
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