CompletedPhase 1

Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media

United States24 participantsStarted 2019-01-07

Plain-language summary

The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.

Who can participate

Age range

18 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

. AOM diagnosis with moderate to severe bulging of the TM and recent (\< 48 hours \[h\]) onset of ear pain.
. Moderate to severe ear pain in the affected ear(s), defined as a score of ≥ 5 (on a scale of 0 10) on the NRS 11 as evaluated by the subject at Screening.
. Generally good health (other than AOM) as determined by evaluation of medical history and physical examination at Screening.
. Negative urine pregnancy test at Screening for all female subjects of childbearing potential.
. Able to read and sign written informed consent prior to study participation.

Exclusion criteria

. Presence of a perforated TM at Screening or had a perforated TM within 6 months (mo) prior to Screening as determined by medical history
. Subjects with tympanostomy tubes
. Acute or chronic otitis externa
. Chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks or longer
. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

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

Number of Participants With Adverse Events

Timeframe: 1 Day

Trial details

NCT IDNCT03766373

SponsorNovus Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-30

Results submitted2019-10-30

View on ClinicalTrials.gov More Acute Otitis Media trials