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.

Age range18 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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)
✕. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
✕. Permanent hearing loss irrespective of otitis media
✕. Subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment

Number of Participants With Adverse Events

Timeframe: 1 Day

NCT IDNCT03766373

SponsorNovus Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-30

Results submitted2019-10-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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)
✕. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
✕. Permanent hearing loss irrespective of otitis media
✕. Subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment