Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EXE844 Sterile Otic Suspension, 0.3%

Tympanostomy Tube Insertion

About this trial

This is an interventional other trial for Otitis Media With Effusion in Children

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion;
Legally Authorized Representative (LAR) must read and sign the informed consent;
Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Menarcheal females;
Previous otologic or otologic-related surgery within the past 30 days or ongoing complications;
Existing perforation of the eardrum;
Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug;
Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study;
Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics;
Weighs less than 8 kg;
Other protocol-specified exclusion criteria may apply.

Sites / Locations

Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EXE844

Arm Description

EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion

Outcomes

Primary Outcome Measures

Maximum Analyte Plasma Concentration (Cmax)

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 in the calculation of the summary statistics.

Time to Reach Maximum Concentration (Tmax)

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 in the calculation of the summary statistics.

Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)

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 in the calculation of the summary statistics.

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)

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 in the calculation of the summary statistics.

Time to Last Measurable Concentration (Tlast)

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 in the calculation of the summary statistics.

Terminal Elimination Half-life (T1/2)

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 in the calculation of the summary statistics.

Secondary Outcome Measures

Full Information

NCT ID

NCT02539654

First Posted

September 1, 2015

Last Updated

July 9, 2018

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT02539654

Brief Title

Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

Official Title

An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 17, 2015 (Actual)

Primary Completion Date

June 24, 2016 (Actual)

Study Completion Date

June 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Media With Effusion in Children, Otitis Media Recurrent

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EXE844

Arm Type

Experimental

Arm Description

EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion

Intervention Type

Drug

Intervention Name(s)

EXE844 Sterile Otic Suspension, 0.3%

Intervention Type

Procedure

Intervention Name(s)

Tympanostomy Tube Insertion

Primary Outcome Measure Information:

Title

Maximum Analyte Plasma Concentration (Cmax)

Description

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 in the calculation of the summary statistics.

Time Frame