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NCT02539654 · ClinicalTrials.gov registry record · Phase 1
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
A Phase 1 study, sponsored by Alcon Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02539654: Completed Phase 1 study, sponsored by Alcon Research.
NCT02539654 is a Phase 1 study that has completed, run by Alcon Research. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02539654, a Phase 1 study, has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
Primary Outcome
Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (\<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (\<0.5 ng/mL) were replaced by one-half the lower limit of quantification
Interventions
- DRUG EXE844 Sterile Otic Suspension, 0.3%
- PROCEDURE Tympanostomy Tube Insertion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-11-17 |
| Est. Completion | 2016-06-24 |
| Phase | Phase 1 |
What the finished NCT02539654 record still lists
NCT02539654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which EXE844 Sterile Otic Suspension, 0.3% is the first listed.
NCT02539654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02539654 about?
NCT02539654 is a clinical study titled "Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)". The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
What is the current status of trial NCT02539654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-11-17. Estimated completion is 2016-06-24.
What interventions are being tested in trial NCT02539654?
The interventions under investigation include: EXE844 Sterile Otic Suspension, 0.3% (DRUG), Tympanostomy Tube Insertion (PROCEDURE).
Who is sponsoring clinical trial NCT02539654?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02539654's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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