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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 is a Phase 1 study that has completed, run by Alcon Research. The registered enrollment target is 14 participants.

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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.

Interventions

  • DRUG EXE844 Sterile Otic Suspension, 0.3%
  • PROCEDURE Tympanostomy Tube Insertion

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2015-11-17
Est. Completion 2016-06-24
Phase Phase 1

Sponsor

Alcon Research

275 total trials

What the Registry Record Tells You About NCT02539654

The ClinicalTrials.gov registry entry for NCT02539654 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alcon Research, which has 275 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which EXE844 Sterile Otic Suspension, 0.3% is the first listed.

NCT02539654 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.