Otitis MediaPhase 1NCT01908764

Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery

A Phase 1 study testing AL-60371 otic suspension in people with Otitis Media, run by Alcon Research.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 6 months to 12 years
Conditions the study is for: Otitis Media
What is being tested?: AL-60371 otic suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Nov 2014to Jan 2015
Phase: Phase 1
Are there results?: None posted in the registry

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

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;
Other protocol-defined inclusion criteria may apply.

Who cannot join

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;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery

Conditions: Otitis Media
Being tested: AL-60371 otic suspension
Keywords: ear tubes, tympanostomy tubes, Otitis Media at the time of Tympanostomy Tube surgery, OMTT
Medical subject headings: Otitis Media

What participants receive

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

AL-60371 otic suspensionDrug

Study groups in NCT01908764
Study group	Role	What they receive
AL-60371/Posology 1	Experimental	AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes Receives: 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 Receives: Drug: AL-60371 otic suspension

What is being measured

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

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 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.

Nov 2014Jan 2015

First posted26 Jul 2013 (estimated)
Study startNov 2014
Primary completionJan 2015 (estimated)
Study completionJan 2015 (estimated)

Why it stopped: Management Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Otitis MediaStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01908764
Sponsor's protocol ID: C-13-023
Status last verified: Oct 2014
First submitted: 24 Jul 2013
Last updated: 8 Mar 2016
Results posted: No
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?

Official record

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

All Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
ClinicalTrials.gov ID: NCT01908764
Acronym / sponsor ID: C-13-023
Conditions: Otitis Media
Keywords: ear tubes, tympanostomy tubes, Otitis Media at the time of Tympanostomy Tube surgery, OMTT
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Management Decision
Enrolment: 0 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jan 2015 (estimated)
Study completion: Jan 2015 (estimated)
First posted: 26 Jul 2013 (estimated)
Results: Not posted in the source record

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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AL-60371/Posology 1	Experimental	Drug: AL-60371 otic suspensionAL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes
AL-60371/Posology 2	Experimental	Drug: AL-60371 otic suspensionAL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes

Who may qualify

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

Key inclusion criteria (5 listed)

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;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (8 listed)

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;

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
AL-60371 otic suspension	Drug	AL-60371/Posology 1, AL-60371/Posology 2

Primary outcome

Maximum observed analyte plasma concentration (Cmax)
Time frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
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).
Time to reach Cmax (Tmax)
Time frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
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).
Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last)
Time frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
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).
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Time frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
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).
Time to last measurable concentration (Tlast)
Time frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
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).
The terminal elimination half (T½)
Time frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
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).

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.

Related trials for Otitis Media

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

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.

Celeste McClean, BS, MT (ASCP) study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AL-60371 otic suspension in people with Otitis Media, run by Alcon Research.

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 5 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: withdrawn, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 observed analyte plasma concentration (Cmax) (time frame: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 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 NCT01908764.

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 8 Mar 2016.