Acute Otitis MediaPhase 2NCT01908803

Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

A Phase 2 study testing AL-60371/AL-817 otic suspension and Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension in people with Acute Otitis Media, run by Alcon Research.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea. Read more about this study

Who is it for?: Ages 6 months to 12 years
Conditions the study is for: Acute Otitis Media
What is being tested?: AL-60371/AL-817 otic suspension and Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: No sites listed yet
Study dates: Dec 2013to Aug 2014
Phase: Phase 2
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

Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
Presence of patent tympanostomy tubes;
Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;
Other protocol-defined inclusion criteria may apply.

Who cannot join

NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
Menarcheal females;
Previous otologic surgery, except tympanic membrane, within one year of study entry;
History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;
Diabetic (controlled or uncontrolled);
Use of prohibited medications;
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)

Read the detailed description

The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Conditions: Acute Otitis Media
Being tested: AL-60371/AL-817 otic suspension, Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension
Keywords: AOMT, tympanostomy tubes, Otorrhea, anti-infective
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/AL-817 otic suspensionDrug
Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspensionDrug
CIPRODEX®

Study groups in NCT01908803
Study group	Role	What they receive
AL-60371/AL-817	Experimental	AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1) Receives: Drug: AL-60371/AL-817 otic suspension
CIPRODEX	Active comparator	Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days Receives: Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension

What is being measured

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

Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.
Measured: Day 3 post-treatment up to Day 8 or Early Exit

Secondary outcomes (2)

Proportion of Subjects With Microbiological Success at the Day 8 Visit
Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.
Measured: Day 8
Median Time (in Days) to Cessation of Otorrhea
Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.
Measured: Time to event, up to Day 8

Timeline

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

Dec 2013Aug 2014

First posted26 Jul 2013 (estimated)
Study startDec 2013
Primary completionAug 2014
Study completionAug 2014

Why it stopped: Management decision

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 Acute 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01908803
Sponsor's protocol ID: C-13-026
Status last verified: Nov 2017
First submitted: 24 Jul 2013
Last updated: 6 Dec 2017
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?

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 Acute Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)
ClinicalTrials.gov ID: NCT01908803
Acronym / sponsor ID: C-13-026
Conditions: Acute Otitis Media
Keywords: AOMT, tympanostomy tubes, Otorrhea, anti-infective
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Management decision
Enrolment: 84 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 26 Jul 2013 (estimated)
Results: Posted 24 Sep 2015

Clinical summary

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

Detailed description

The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
AL-60371/AL-817	Experimental	Drug: AL-60371/AL-817 otic suspensionAL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
CIPRODEX	Active comparator	Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspensionCiprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days

Who may qualify

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

Key inclusion criteria (6 listed)

Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;
Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;
Presence of patent tympanostomy tubes;
Refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities;
Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;

Key exclusion criteria (8 listed)

NOT otorrhea-free for at least seven days following tympanostomy tube surgery;
Menarcheal females;
Previous otologic surgery, except tympanic membrane, within one year of study entry;
History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);
Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;

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/AL-817 otic suspension	Drug	AL-60371/AL-817
Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspensionCIPRODEX®	Drug	CIPRODEX

Primary outcome

Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit
Time frame: Day 3 post-treatment up to Day 8 or Early Exit
A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.

2 secondary outcomes

Proportion of Subjects With Microbiological Success at the Day 8 Visit
Time frame: Day 8
Median Time (in Days) to Cessation of Otorrhea
Time frame: Time to event, up to Day 8

Results and safety

Results posted to the registry on 24 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AL-60371/AL-817	46	42
CIPRODEX	24	23

Primary outcome: Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit

Time frame: Day 3 post-treatment up to Day 8 or Early Exit. Number. Unit: percentage of subjects

Measure	AL-60371/AL-817 n = 39	CIPRODEX n = 22
Value	38.5	31.8

Population analysed: This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of subject participation in the study (8-10 days). 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 84 (0%)	0 of 84 (0%)	Not reported
AL-60371/AL-817	0 of 44 (0%)	3 of 44 (6.8%)	Not reported
CIPRODEX	0 of 24 (0%)	1 of 24 (4.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute 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.

Clinical Manager, GCRA, Pharma study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AL-60371/AL-817 otic suspension and Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension in people with Acute 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 6 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: stopped early, as of the sponsor's last update on 6 Dec 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 24 Sep 2015). 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?

Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit (time frame: Day 3 post-treatment up to Day 8 or Early Exit). 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 NCT01908803.

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 6 Dec 2017.