NCT03766373CompletedPhase 1
Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media
Novus Therapeutics, Inc4 sites in 1 country24 target enrollmentStarted: January 7, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 4
- Primary Endpoint
- Number of Participants With Adverse Events
Study Overview
Brief Summary
The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •includes but is not limited to:
- •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
- •includes but is not limited to:
- •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
- •Subjects with craniofacial abnormalities (eg, cleft palate, Down's Syndrome)
- •Subjects with erythema of the TM without other evidence of otitis media
- •Seborrheic dermatitis involving the affected external ear canal or pinna
- •Use of medications with known vasoconstrictive properties (eg, decongestants [Afrin®, Sudafed®]) currently or within 2 h prior to Screening
- •Use of oral analgesics < 2 h prior to Screening or Baseline (oral analgesics > 2 h are permitted as long as ear pain criteria are met per Inclusion Criteria)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: 1 Day
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
Loading locations...
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