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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 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 8 participants.
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).
Interventions
- DRUG Azithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-12 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01919996
The ClinicalTrials.gov registry entry for NCT01919996 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Azithromycin is the first listed.
NCT01919996 reports 0 study locations.
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.
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