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    Summary
    EudraCT Number:2014-004164-38
    Sponsor's Protocol Code Number:A0661190
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-06
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004164-38
    A.3Full title of the trial
    An Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release (IR) Or Extended-Release (ER) Formulation In Pediatric Subjects With Acute Otitis Media (AOM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
    A.4.1Sponsor's protocol code numberA0661190
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00796224
    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 SponsorPfizer 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.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 Yes
    D.2.1.1.1Trade name Zithromax
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc
    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 nameazithromycin
    D.3.2Product code CP-62,993
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNazithromycin
    D.3.9.1CAS number 83905-01-5
    D.3.9.2Current sponsor codeCP-62,993
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.9.4EV Substance CodeSUB05660MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute otitis media
    E.1.1.1Medical condition in easily understood language
    Ear Infection
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the pharmacokinetics of azithromycin following a single dose of either 30 milligram per kilogram (mg/kg) IR or 60 mg/kg ER formulation in pediatric subjects with AOM.
    E.2.2Secondary objectives of the trial
    azithromycin following a single dose of either 30 mg/kg IR or 60 mg/kg ER formulation in pediatric subjects with AOM.
    To evaluate clinical response of azithromycin following a single dose of either 30 mg/kg IR or 60 mg/kg ER formulation in pediatric subjects with AOM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female pediatric subjects age 6 months to 6 years old inclusive.
    2. For each subject, the parent(s) or legal guardian(s) must be willing and able to provide written informed consent. Where appropriate, the assent of the subject will also be obtained. Subject’s age and relationship to the parent(s) or legal guardian(s) must be verified and documented.
    3. Have clinical signs or symptoms of acute otitis media in at least one ear as follows:
    • Purulent otorrhea of less than or equal to (≤) 24 hours duration
    • At least 2 otoscopic signs of middle ear effusion
    • Decreased or absent tympanic membrane mobility by pneumatic otoscopy
    • Yellow or white discoloration of tympanic membrane
    • Opacification of tympanic membrane (other than scarring)
    4. At least 1 indicator of acute inflammation to support the diagnosis of AOM:
    • Ear pain, including unaccustomed tugging or rubbing
    • Marked redness of tympanic membrane
    • Distinct fullness or bulging of tympanic membrane
    5. Subjects may be inpatients or outpatients. Subjects or their parent(s) or guardian(s) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
    2. Inability to take oral medications or any condition possibly affecting drug absorption.
    3. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
    4. Previously diagnosed disease(s) of immune function.
    5. Known or suspected hypersensitivity, or intolerance to azithromycin or other
    macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor.
    6. Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
    7. Any medical condition that could interfere with the evaluation of the study drug and would make the subject unsuitable for enrollment, including: Tympanostomy tubes in place, Otitis externa, evidence of chronic middle ear disease including retraction pockets, cholesteatoma and erforations of the tympanic membrane in the affected ear for less than 24 hours prior to study entry or Mastoiditis.
    8. Subjects who have consumed grapefruit or grapefruit containing products within 7 days prior to the dose of study medication, or intending to consume these products during the study.
    9. Unwilling or unable to comply with the Life Style Guidelines described in the Protocol of the study.
    10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Predose or 0 to 72 Hours
    E.5.2Secondary end point(s)
    - Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)
    - Maximum Observed Plasma Concentration (Cmax) of Azithromycin
    - Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin
    - Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)
    - Number of Subjects With a Clinical Response
    - Adverse Events (AEs) and Serious AEs (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Predose or 0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
    - Predose or 0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
    - Predose or 0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose
    - 1,2,3,4,8,24,48,72 hours post-dose
    - Days 7,8,9 or 10
    - Baseline up to 28 days
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Costa Rica
    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.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 38
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 19
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 19
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 38
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Male or female pediatric subjects aged 6 months to 6 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 38
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Costa Rica
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