Otitis Media With Effusion in ChildrenPhase 1NCT02539654

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

A Phase 1 study testing EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion in people with Otitis Media With Effusion in Children and Otitis Media Recurrent, run by Alcon Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 months to 12 years
Conditions the study is for: Otitis Media With Effusion in Children, Otitis Media Recurrent
What is being tested?: EXE844 Sterile Otic Suspension, 0.3% and Tympanostomy Tube Insertion
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2015to 24 Jun 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

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

Conditions: Otitis Media With Effusion in Children, Otitis Media Recurrent
Being tested: EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EXE844 Sterile Otic Suspension, 0.3%Drug
Tympanostomy Tube InsertionProcedure or surgery

Study groups in NCT02539654
Study group	Role	What they receive
EXE844	Experimental	EXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion Receives: Drug: EXE844 Sterile Otic Suspension, 0.3%; Procedure: Tympanostomy Tube Insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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.
Measured: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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.
Measured: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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.
Measured: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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.
Measured: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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.
Measured: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201524 Jun 2016

First posted3 Sep 2015 (estimated)
Study start17 Nov 2015
Primary completion24 Jun 2016
Study completion24 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Otitis Media With Effusion in ChildrenStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02539654
Sponsor's protocol ID: EXE844b-C003
Status last verified: Nov 2017
First submitted: 1 Sep 2015
Last updated: 7 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Otitis Media With Effusion in Children trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose, Pharmacokinetic Study of EXE844 Sterile Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
ClinicalTrials.gov ID: NCT02539654
Acronym / sponsor ID: EXE844b-C003
Conditions: Otitis Media With Effusion in Children, Otitis Media Recurrent
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 17 Nov 2015 (actual)
Primary completion: 24 Jun 2016 (actual)
Study completion: 24 Jun 2016 (actual)
First posted: 3 Sep 2015 (estimated)
Results: Posted 10 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EXE844	Experimental	Drug: EXE844 Sterile Otic Suspension, 0.3%, Procedure: Tympanostomy Tube InsertionEXE844 Sterile Otic Suspension, 0.3%, single ototopical dose (4 drops) in each ear following tympanostomy tube insertion

Who may qualify

Ages: 6 months to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EXE844 Sterile Otic Suspension, 0.3%	Drug	EXE844
Tympanostomy Tube Insertion	Procedure or surgery	EXE844

Primary outcome

Maximum Analyte Plasma Concentration (Cmax)
Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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)
Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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)
Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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)
Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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)
Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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)
Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose
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.

Results and safety

Results posted to the registry on 10 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EXE844	14	14

Primary outcome: Maximum Analyte Plasma Concentration (Cmax)

Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	EXE844 n = 14
AL-60371	2.44 (2.411)
AL-91591	1.61 (1.141)

Population analysed: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]

Primary outcome: Time to Reach Maximum Concentration (Tmax)

Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose. Median (Full Range). Unit: hours

Measure	EXE844 n = 14
AL-60371	0.59 (0.48 to 2.1)
AL-91591	1.00 (0.55 to 2.17)

Population analysed: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]

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

Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	EXE844 n = 9
AL-60371	8.66 (6.406)
AL-91591	3.94 (4.136)

Population analysed: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]

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

Time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	EXE844 n = 8
AL-60371	10.60 (7.764)
AL-91591	19.90 (NA)

Population analysed: PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte \[EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)\]

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 20 days). AE reporting began after parent/legally authorized representative (LAR) signed informed consent and if applicable, after participant signed assent. AEs are reported as pre-treatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 14 (0%)	0 of 14 (0%)	0 of 14
EXE844	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Manager, GCRA, Pharma study director

Alcon Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Analyte Plasma Concentration (Cmax) (time frame: Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.