NCT01908764

Brief Summary

The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

July 24, 2013

Last Update Submit

March 4, 2016

Conditions

Otitis Media

Keywords

ear tubestympanostomy tubesOtitis Media at the time of Tympanostomy Tube surgeryOMTT

Outcome Measures

Primary Outcomes (6)

  • Maximum observed analyte plasma concentration (Cmax)

    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose

  • Time to reach Cmax (Tmax)

    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose

  • Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last)

    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose

  • Area under the concentration-time curve from 0 to infinity (AUC0-∞)

    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose

  • Time to last measurable concentration (Tlast)

    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose

  • The terminal elimination half (T½)

    The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).

    Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose

Study Arms (2)

AL-60371/Posology 1

EXPERIMENTAL

AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes

Drug: AL-60371 otic suspension

AL-60371/Posology 2

EXPERIMENTAL

AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes

Drug: AL-60371 otic suspension

Interventions

AL-60371 otic suspensionDRUG
AL-60371/Posology 1AL-60371/Posology 2

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Requires bilateral myringotomy and tympanostomy tube insertion;
  • Provides informed consent (parent/legal guardian);
  • Signs assent form where applicable (subject);
  • Accompanied by parent/legal guardian at each visit;

You may not qualify if:

  • Menarcheal females;
  • Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;
  • Use of excluded medications within one week prior to surgery and for the duration of the study;
  • Requires another surgical procedure in addition to the myringotomy;
  • Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;
  • Participation in any other investigational study within 30 days before entry into this study or along with this study;
  • Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Celeste McClean, BS, MT (ASCP)

    Alcon Research

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

November 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 8, 2016

Record last verified: 2014-10