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    Summary
    EudraCT Number:2004-002619-10
    Sponsor's Protocol Code Number:OP-634-001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-09-29
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-002619-10
    A.3Full title of the trial
    A Phase IIIb, Randomized, Double-Blind, Multicenter, Parallel Group Study
    to Assess the Efficacy and Safety of Oral Gemifloxacin 320 mg Once Daily
    for 5 Days Versus Oral Gemifloxacin 320 mg Once Daily for 7 Days for the
    Treatment of Mild to Moderate Community Acquired Pneumonia
    A.4.1Sponsor's protocol code numberOP-634-001
    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 SponsorOscient Pharmaceuticals
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Factive TM
    D.2.1.1.2Name of the Marketing Authorisation holderOscient Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameFactive TM
    D.3.4Pharmaceutical form Capsule*
    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 INNGemifloxacin mesylate
    D.3.9.1CAS number 204519-65-3
    D.3.9.2Current sponsor codeGemifloxacin mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    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 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 placeboCapsule*
    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
    Mild to moderate community acquired bacterial pneumonia.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10010120
    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 that the clinical efficacy of oral gemifloxacin 320 mg once daily
    for 5 days is at least as good as oral gemifloxacin 320 mg once daily for 7 days,
    for the treatment of mild to moderate CAP.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of oral gemifloxacin 320 mg once daily for 5 days,
    compared with oral gemifloxacin 320 mg once daily for 7 days, in patients with
    mild to moderate CAP.
    To evaluate the bacteriological efficacy of oral gemifloxacin 320 mg once daily
    for 5 days, compared with oral gemifloxacin 320 mg once daily for 7 days, in
    patients with mild to moderate CAP.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Male or female patients may be included in this study if the following criteria are met:
    1. Patient is aged 18 years or more.
    2. Patient has given written dated informed consent to participate in the study.
    3. Patient has a clinical diagnosis of community acquired bacterial pneumonia
    characterised by fever (Fever defined as an oral temperature of 38°C or more, tympanic temperature of 38°C or more, or rectal temperature of 38.5°C or more) and at least two of the following signs and symptoms:
    _ -new or increased cough;
    _ -purulent sputum or a change in sputum characteristics;
    _ -auscultatory findings on pulmonary examination of rales and/or
    evidence of pulmonary consolidation (dullness on percussion, crackles
    on auscultation, bronchial breathing);
    _ -dyspnea;
    4. Patients with a chest radiograph showing the presence of new or progressive
    infiltrate(s), consolidation, or pleural effusion consistent with pneumonia.
    5. Patient is willing and able to comply with the study protocol.
    6. Patient is expected to survive the duration of the study protocol.
    7. Female patients of child-bearing potential have a negative urine pregnancy
    test prior to enrollment (including those who are practising birth control, those with tubal ligation and those less than one year post menopausal).
    NOTE: A serum pregnancy test will also be performed by the central
    laboratory on all female patients of child-bearing potential.
    E.4Principal exclusion criteria
    1. Females who are pregnant, lactating, planning a pregnancy during the study,
    or of child-bearing potential and not using an accepted method of
    contraception (i.e. surgical sterility, intra-uterine contraceptive device, oral contraceptive plus barrier contraceptive, other hormone delivery systems plus barrier contraceptive, diaphragm or condom in combination with
    contraceptive cream, jelly or foam).
    2. Patients with known or suspected hypersensitivity to quinolone antibacterials or not suitable for therapy as described in the contraindications, warnings or precautions sections of the Investigator’s Brochure for gemifloxacin for seven days.
    3. Patients with a history of tendonitis while taking fluoroquinolones.
    NOTE: patients developing tendonitis during the study should be
    withdrawn.
    4. Patients with hospital-acquired pneumonia (i.e., pneumonia acquired more
    than 48 hours after hospital admission) or who have been hospitalized within
    2 weeks preceding entry into the study.
    5. Patients with a pre-therapy chest radiograph negative for chest infiltrates, or inconsistent with a diagnosis of CAP.
    6. Patients with aspiration pneumonia.
    7. Patients with known localized bronchial obstruction or a history of postobstructive pneumonia (this does not exclude patients who have chronic
    obstructive pulmonary disease).
    8. Patients with cystic fibrosis, active tuberculosis, bronchiectasis, or active pulmonary malignancies (with clinical signs and symptoms as opposed to a radiographic-only diagnosis).
    9. Presence of a complicating infection or disease that would compromise
    treatment evaluation of the study medication (e.g. septic shock, empyema,
    septic arthritis, meningitis).
    10. Patients with a life threatening or serious underlying disease, which is
    unstable.
    11. Patients requiring parenteral antibacterial therapy.
    12. Patients who have received more than 24 hours treatment with any other
    antibacterial for this current episode of CAP
    13. Patients who are immunocompromised.
    14. Patients who are known to be HIV positive and with a CD4 count with less than 500 cells/mm3 within the past 3 months.
    15. Patients receiving systemic steroids at a dose of more than 10mg per day of prednisone (or the equivalent)
    16. Patients with active alcohol or drug abuse.
    17. Patients who are concurrently receiving sucralfate.
    18. Treatment with an investigational drug, vaccine or device within 30 days or 5 half lives (whichever is longer) of study entry.
    19. Patients who have been previously enrolled in this study or any other study involving gemifloxacin (except healthy volunteer studies).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Evaluation:
    Clinical response (success or failure) at follow-up is the primary efficacy
    parameter.
    For patients who were 'clinical successes' at end of therapy, the investigator will
    review the clinical information obtained at the follow-up evaluation, and will
    evaluate each patient's clinical outcome as follows:

    Follow-Up Clinical Success: Sufficient improvement or resolution of signs and
    symptoms of CAP for patients who were clinical successes at the end of therapy
    visit, such that no additional antibacterial therapy is required for CAP.

    Clinical Recurrence: Reappearance of signs and symptoms of CAP for patients
    who were clinical successes at the end of therapy, such that additional
    antibacterial therapy is required for CAP.

    Unable to Determine: A valid assessment of clinical outcome could not be made
    (e.g. the patient was lost to follow-up or did not consent to a clinical
    examination).
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Treatment once daily for 5 days followed by placebo for 2 days vs. treatment once daily for 7 days.
    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 Yes
    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 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
    The study end date will be the date of last patient, last study visit.
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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 2004-09-29. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 232
    F.4.2.2In the whole clinical trial 459
    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 Decision2004-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
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