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NCT01919996 · ClinicalTrials.gov registry record · Phase 2
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01919996: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT01919996 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01919996, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory post-marketing requirement to provide data regarding visual abilities in children taking azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary objective of the study is to examine the incidence of clinically significant worsening in any of the following ophthalmic exams: best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of approximately 30 pediatric patients taking azithromycin oral solution for treatment of an authorized indication of use (pharyngitis/ tonsillitis).
Primary Outcome
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 assessme
Interventions
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
Why NCT01919996 stopped before completion
NCT01919996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Azithromycin is the first listed.
NCT01919996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01919996 about?
NCT01919996 is a clinical study titled "PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients". This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory post-marketing requirement to provide data regarding visual abilities in children taking azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary objective of the study is to examine th...
What is the current status of trial NCT01919996?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2013-12. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01919996?
The interventions under investigation include: Azithromycin (DRUG).
Who is sponsoring clinical trial NCT01919996?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01919996's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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