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    Summary
    EudraCT Number:2006-003944-42
    Sponsor's Protocol Code Number:REP-FAR-005
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-18
    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 ConcernedLatvia - SAM
    A.2EudraCT number2006-003944-42
    A.3Full title of the trial
    Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo in the Treatment of Acute Exacerbation of Chronic Bronchitis”
    A.4.1Sponsor's protocol code numberREP-FAR-005
    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 SponsorReplidyne, Inc.
    B.1.3.4CountryUnited States
    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 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 nameFaropenem medoxomil
    D.3.2Product code REP319740
    D.3.4Pharmaceutical form Film-coated 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 INNFaropenem medoxomil
    D.3.9.1CAS number 141702-36-5
    D.3.9.2Current sponsor codeREP319740
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 to mg
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeFaropenem medoxomil is synthetically derived from the core structures of penicillin and cephalosporin molecules
    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
    acute exacerbation of chronic bronchitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000744
    E.1.2Term Acute exacerbation of chronic bronchitis NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superioity of faropenem medoxomil versus placebo, in terms of clinical response, in the treatment of the subjectswith a microbiologically documented acute exacerbation of chronic bronchitis
    E.2.2Secondary objectives of the trial
    Clinical response (as measured by clinical signs and symptoms) and sputum purulence at the During Therapy Visit (Day 2 to 5) will be compared between treatment groups in the clinically evaluable population;
    Clinical response at the TOC (Test-of-Cure) Visit in the Intent-to Treat (ITT) population;
    Clinical response at the Late Post-Therapy Follow-up Visit in the clinically evaluable population;
    Patient Reported Outcomes using a Clinical COPD Questionnaire at Visit 1 (Pre-Therapy), Visit 2 (During Therapy), Visit 3 TOC (Test-of-Cure) and Visit4 (Late Post-Therapy Follow-Up)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Male or non-pregnant female outpatients age ≥ 35 years with significant COPD (GOLD criteria I, II or III), chronic cough and sputum production and an acute exacerbation of chronic bronchitis;
    b. have a histiry (past or current) of smoking (≥ 10 pack-years);
    c. Have evidence of airflow obstruction (within a year prior to the current exacerbation or during the current exacerbation and then reconfirmed after recovery), defined as:
    - Forced expiratory volume in one second (FEV1) % predicted ≥ 35 years and
    - Ratio of FEV1 to forced capacity (FVC) of 0.70
    d. Have a clinical diagnosis of AECF defined as:
    - Cough and sputum production on most days for at least 3 consecutivemonths for > 2 successive years
    - All of the following cardinal symptoms must be present:
    * Increase in or worsening of cough
    * Increase or worsening of dyspnea
    * Increase in sputum volume
    * Increase in sputum purulence
    e. Patient must provide a purulent or muco-purulent sputum by deep expectoration for culture and susceptibility testing on the day of study enrollment;
    f. If female, the subject must:
    - be postmenopausal for at least 1 year, OR
    - have had a bilateral oophorectomy and/or hysterectomy, OR
    - have had a bilateral tubal ligation or otherwise be incapable of pregnancy, OR
    g. if of childbearing potential, the subject must:
    - have maintained her normal menstrual pattern duting the 3 months prior to study entry, AND
    - have taken hormonal contraceptives for at least 1 month prior to study entry, or agree to use spermicide and barrier methods or have been using another acceptable method of contraception and agree to continue with the same method during the study, AND
    - have had a negative urine β- subunit hCG pregnancy test sensitive to at least 50 µU/mL of β-hCG immediately prior to study entry;
    h. female subjects who become pregnant during participation must be promptly withdrawn from the trial
    The subject is to be withdrawnfrom the study if the urine pregnancy test is positive;
    i. Read and sign the Informed Consent
    j. Subject is an appropriate candidate for oral antibacterial therapy
    E.4Principal exclusion criteria
    a. History of hypersensitivity to faropenem medoxomil or any of the components of the product or a history of an anaphylactic reaction to β-lactams (e.g., penicillins or cephalosporins);
    b. Chest x-ray or other radiographic documentation of an underlying pneumonia;
    c. Known lung or chest cavity malignancy active within the past 5 years;
    d. Known concurrent medically active conditions likely to interfere with the evaluation of efficacy (e.g., pulmonary tuberculosis, bronchiectasis, cystic fibrosis, etc.)
    e. Known neutropenia (< 1000 cells/mm3), or CD4 count of < 200 cells/mm3, or on highly active antiretroviral therapy (HAART). An HIV test is not required;
    f. The need for hospitalization or intravenous antibiotics for this exacerbation;
    g. Hospitalization for any cause within two weeks prior to study entry, lasting ≥ 48 hours;
    h. Any previous course of a systemic antibacterial agent within the last 2 weeks;
    i. Subject has severe renal insufficiency (CrCl < 30 mL/min) and/or severe hepatic insufficiency (Childs-Pugh Class C);
    j. Previous treatment under this Protocol;
    k. Subject is pregnant or breastfeeding;
    l. Receipt of any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the study period);
    m. Employees and/or family members of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.
    Subjects will be enrolled before the results of clinical and microbiological laboratory results are available.
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis of efficacy is the comparison of the clinical response rates of faropenem medoxomil to placebo at the Test-of-Cure visit in the modified Intent-to-Treat population
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    For most individual subjects, the trial ends at the Late Post-Therapy Follow-up visit inquiring about interim SAE experiences. Thus, the trial end is the time when the last subject has completed the follow-up visit or the follow-up SAE query contact has been completed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 611
    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)
    normal treatment of condition
    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 Decision2007-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-06
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