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    The EU Clinical Trials Register currently displays   44306   clinical trials with a EudraCT protocol, of which   7355   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).

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    Summary
    EudraCT Number:2016-001119-19
    Sponsor's Protocol Code Number:A0661206
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-04-13
    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 number2016-001119-19
    A.3Full title of the trial
    Ocular Effects Of Azithromycin Oral Solution In Pediatric Patients With Pharyngitis/tonsillitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Potential of Azithromycin to Cause Eye Problems in Children
    A.4.1Sponsor's protocol code numberA0661206
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01919996
    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.5.5Fax number13037391119
    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 Azithromycin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer S.L., Spain
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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-062993
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNAzithromycin
    D.3.9.1CAS number 83905-01-5
    D.3.9.3Other descriptive nameAzithromycin Hydrate
    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 number40
    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
    pharyngitis/tonsillitis
    E.1.1.1Medical condition in easily understood language
    pharyngitis/tonsillitis
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10034835
    E.1.2Term Pharyngitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10044008
    E.1.2Term Tonsillitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to examine the incidence of clinically significant worsening in any of the following ophthalmic evaluations: BCVA (distance), color vision, Amsler grid, anterior segment biomicroscopy, and dilated fundus examinations in a group of approximately 30 pediatric patients taking azithromycin oral solution for treatment of pharyngitis/tonsillitis.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study include examination of (i) the incidence of clinically significant improvement in any of the following ophthalmic evaluations: BCVA (distance), color vision, Amsler grid, anterior segment biomicroscopy, or dilated fundus examination; (ii) the incidence of any clinically significant change (improvement or worsening) in any of the following ophthalmic evaluations: BCVA (distance), color vision, Amsler grid, anterior segment biomicroscopy, or dilated fundus examination; and (iii) general safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Generally healthy male or female subject, aged 12 to 17 years, who required outpatient treatment for an acute pharyngitis/tonsillitis infection that was appropriate to treat with oral azithromycin.
    2. Subjects must have had a positive rapid antigen detection test (RADT) at baseline.
    3. Subject was sighted in both eyes and has no known history of any clinically significant eye disease or condition, apart from a need for corrective lenses.
    E.4Principal exclusion criteria
    1. Subjects with known hypersensitivity to azithromycin, erythromycin, or any macrolide or ketolide antibiotic.
    2. Subjects who had taken another antibiotic within the previous 3 days, or had taken azithromycin (any formulation, including sustained release) within the past 4 weeks.
    3. Subjects with clinical evidence or current/past history of: impaired hepatic or renal function; clinically significant congenital or acquired cardiac disease including cardiac rhythm disorders; myasthenia gravis or other significant neuromuscular disorder; or any other disease or condition that could have put the subject at increased risk for injury if he/she participated in the study.
    4. Subjects with increased risk of QT prolongation, including known personal or family history of prolonged QT syndrome, serious ventricular arrhythmia or family history of sudden cardiac death; subjects currently receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classes IA and III and antipsychotic agents, antidepressants and fluoroquinolones; subjects with electrolyte disturbance, particularly in cases of hypokalemia and hypomagnesemia; subjects with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
    5. Subjects with chronic diseases of the gastrointestinal tract which might have either adversely affected absorption of the drug and/or put the subject at increased risk for injury in the event antibiotic associated diarrhea or similar illness occurred.
    6. Subjects with a medical condition at baseline that required concomitant treatment with a drug known to have effects on vision (ie, a drug whose package insert reported pharmacologic effects on the eye or contained any specific warning of possible adverse effects on the eye or vision based on clinical study results).
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects experiencing a clinically significant worsening (final visit compared to baseline) in at least 1 of the following ocular safety assessments to be performed in the study: BCVA (distance), color vision, Amsler grid, anterior segment biomicroscopy, or dilated indirect ophthalmoscopy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    1. The proportions of subjects experiencing a clinically significant improvement in BCVA (distance), color vision, Amsler grid, anterior segment biomicroscopy, or dilated indirect ophthalmoscopy.
    2. The proportions of subjects experiencing a clinically significant change (improvement or worsening) in BCVA (distance), color vision, Amsler grid, anterior segment biomicroscopy, or dilated indirect ophthalmoscopy.
    3. General safety.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 14.
    2. Day 14.
    3. Throughout the study.
    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 No
    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) 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 No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    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
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months8
    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: 30
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children under the age of 18
    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 30
    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: United States
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