Status:
COMPLETED
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
Lead Sponsor:
Novus Therapeutics, Inc
Conditions:
Acute Otitis Media
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03766373
Start Date
January 7 2019
End Date
January 30 2019
Last Update
December 5 2019
Active Locations (2)
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1
US Clinical Research Group, LLC.
Bellflower, California, United States, 90706
2
Vista Health Research
Miami, Florida, United States, 33176