Clinical Trial Results:
OCULAR EFFECTS OF AZITHROMYCIN ORAL SOLUTION IN PEDIATRIC PATIENTS WITH PHARYNGITIS/TONSILLITIS
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Summary
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EudraCT number |
2016-001119-19 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
05 Nov 2015
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Results information
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Results version number |
v2(current) |
This version publication date |
10 Jun 2016
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First version publication date |
05 May 2016
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A0661206
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01919996 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 East 42nd Street, New York, United States, 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
22 Mar 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Oct 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Nov 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of the study was to examine the incidence of clinically significant worsening in any of the following ophthalmic evaluations: best corrected visual activity (BCVA) (distance), color vision Farnsworth Munsell 100 Hue Test (FM-100), Amsler grid, anterior segment biomicroscopy, and dilated fundus examination, in a group of approximately 30 pediatric participants taking azithromycin oral solution for treatment of an authorized indication of use (pharyngitis/tonsillitis).
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Protection of trial subjects |
This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) GCP Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of study participants.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Dec 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
8
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The sample size of 30 completed participants was specified by Food and Drug Administration (FDA) in the Post Marketing Commitment (PMC). Of the 30 pediatric participants planned for the study, 11 were screened and 8 participants received study treatment. | ||||||
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Pre-assignment
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Screening details |
This was a prospective, non-comparative, open-label, single-arm study of azithromycin oral solution in 30 pediatric participants (aged 12 to 17 years) with pharyngitis/ tonsillitis who could be treated with azithromycin for their infection. The study design was intended to align with request from FDA to conduct the study. | ||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
This was an open-label study.
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Arms
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Arm title
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Azithromycin | ||||||
Arm description |
All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Azithromycin
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Investigational medicinal product code |
CP 062993
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
All participants received azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4 and 5.
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Baseline characteristics reporting groups
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Reporting group title |
Azithromycin
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Reporting group description |
All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Azithromycin
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Reporting group description |
All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5. | ||
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End point title |
Occurrence of a clinically significant worsening based on five ophthalmic examinations [1] | ||||||||||||||
End point description |
Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.
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End point type |
Primary
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End point timeframe |
14 days
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was provided for the primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Occurrence of a clinically significant improvement based on five ophthalmic examinations | ||||||||||||||
End point description |
1 or more of these conditions are clinically significant improvement based on five ophthalmic exams:1) clinically significant improvement in BCVA(distance) at the final visit, in either eye, defined as an increase in score of 5 or more letters from baseline in ETDRS BCVA.2) Assessment of abnormal clinically significant at baseline and normal or abnormal, non-clinically significant at final visit in color vision(FM-100) in either eye. 3) Assessment of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5)Assessments of abnormal clinically significant at baseline and normal/abnormal, nonclinically significant at final visit in dilated ophthalmoscopy in any of the 5 eye structures in either eye.
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End point type |
Secondary
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End point timeframe |
14 days
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Occurrence of a clinically significant change (improvement or worsening) based on five ophthalmic examinations | ||||||||||||||
End point description |
Clinically significant change (improvement or worsening) is based on five ophthalmic exams at baseline and the final visit. Any 1 or more of these conditions are a clinically significant change: 1) A worsening in BCVA (distance), as defined in outcome measure 1 OR an improvement in BCVA (distance) as defined in outcome measure 2. 2) A worsening in color vision (FM-100), as defined in outcome measure 1 OR an improvement in color vision (FM-100) as defined in outcome measure 2. 3) A worsening in Amsler Grid, as defined in outcome measure 1, OR an improvement in Amsler Grid, as defined in outcome measure 2. 4) A worsening in anterior segment biomicroscopy, as defined in outcome measure 1 OR an improvement in anterior segment biomicroscopy as defined in outcome measure 2. 5) A worsening in dilated indirect ophthalmoscopy, as defined in outcome measure 1 OR an improvement in dilated indirect ophthalmoscopy as defined in outcome measure 2.
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End point type |
Secondary
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End point timeframe |
14 days
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| No statistical analyses for this end point | |||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
From Day 1 up to 28 calendar days after the last administration of the study medication (up to 40 days).
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Adverse event reporting additional description |
The safety population included all enrolled participants that took at least one dose of study medication.
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Assessment type |
Non-systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Azithromycin
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Reporting group description |
All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5. | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no non-serious adverse events reported for this study. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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12 Jun 2013 |
Objectives and endpoints were updated to indicate that anterior segment biomicroscopy and dilated fundus examination (rather than fundus photography) were analyzed. In addition, intra-ocular pressure had been removed as an endpoint, as it does not directly support a study objective. Several statements in the inclusion criteria were considered guidance for investigators, rather than criteria. These were now sub-bullets for the respective criteria. Although culture and susceptibility testing results were not required prior to enrollment, these data were collected on the case report forms. Ophthalmologic examinations were updated to reflect detailed description of eye structures which were evaluated. Early Treatment Diabetic Retinopathy Study test instructions were included in an appendix. FM-100 Hue test description was updated to be consistent with the test manual to require 2 tests for each eye and recording of the best test results. Physical examination body systems were removed. The two lowest weight classes for children (<25 kg) were removed, as these would be below the 5th percentile for 12-year-olds. Collection of adverse event and concomitant medication information was recorded at the Day 3-5 and Day 6-13 telephone contact visits. The parent/guardian was contacted for the Day 33 telephone contact visit. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The study was terminated after the FDA released the Sponsor from the PMC. The FDA deemed the study as impracticable, given the azithromycin dose studied in the PMC was not used and the available data did not identify a signal for ocular toxicity. | |||
