TerminatedPhase 3

Safety and Efficacy of Moxidex Otic

Stopped: Management decision

United States400 participantsStarted 2010-02

Plain-language summary

The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.

Who can participate

Age range

6 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 6 months to 12 years of age * Ear tubes in one or both ears * Ear drainage visible by parent/guardian * Ear drainage less than 21 days * Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Patients not otorrhea-free for 7 or less following tympanostomy tube surgery * Ear tube with antimicrobial activity; ear tube longer than 2.5mm * Non-tube otorrhea * No otic surgery other than tube placement in the last year * No menarchial females; no diabetic patients * No patients with any disease or condition that would negatively affect the conduct of the study * No patients taking any other systemic antimicrobial therapy during the study * Patient must meet certain medication washouts to be eligible * Analgesic use (other than acetaminophen) is not allowed * Patients may not be predisposed to neurosensory hearing loss * Other protocol-defined exclusion criteria may apply

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Cure at End of Treatment

Timeframe: Day 8

Trial details

NCT IDNCT01071902

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

View on ClinicalTrials.gov More Acute Otitis Media trials

Who can participate

Age range

6 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.