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

Novus Therapeutics

Status and phase: Completed; Phase 1

Conditions: Acute Otitis Media

Treatments: Combination Product: Drug: Placebo 0mg; Combination Product: Drug: OP0201 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03766373

OP0201-C-004

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria includes but is not limited to:

1. AOM diagnosis with moderate to severe bulging of the TM and recent (< 48 hours [h]) onset of ear pain.
2. 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.
3. Generally good health (other than AOM) as determined by evaluation of medical history and physical examination at Screening.
4. Negative urine pregnancy test at Screening for all female subjects of childbearing potential.
5. Able to read and sign written informed consent prior to study participation.

Exclusion Criteria includes but is not limited to:

1. Presence of a perforated TM at Screening or had a perforated TM within 6 months (mo) prior to Screening as determined by medical history
2. Subjects with tympanostomy tubes
3. Acute or chronic otitis externa
4. Chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks or longer
5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
7. Permanent hearing loss irrespective of otitis media
8. Subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment
9. Subjects with craniofacial abnormalities (eg, cleft palate, Down's Syndrome)
10. Subjects with erythema of the TM without other evidence of otitis media
11. Seborrheic dermatitis involving the affected external ear canal or pinna
12. Use of medications with known vasoconstrictive properties (eg, decongestants [Afrin®, Sudafed®]) currently or within 2 h prior to Screening
13. 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Drug: OP0201

Active Comparator group

Treatment:

Combination Product: Drug: OP0201 20mg

Drug: Placebo

Placebo Comparator group

Treatment:

Combination Product: Drug: Placebo 0mg