Acute Otitis Media
Conditions
Brief summary
The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.
Interventions
COMBINATION_PRODUCTDrug: OP0201 20mg
OP0201
COMBINATION_PRODUCTDrug: Placebo 0mg
Placebo
Sponsors
Novus Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | 1 Day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug: OP0201 Drug: OP0201 20mg: OP0201 | 12 |
| Drug: Placebo Drug: Placebo 0mg: Placebo | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Drug: OP0201 | Total | Drug: Placebo |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 13.24 | 49.5 years STANDARD_DEVIATION 14.98 | 45.7 years STANDARD_DEVIATION 16.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 16 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 16 Participants | 7 Participants |
| Region of Enrollment United States | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug: OP0201 | Number of Participants With Adverse Events | 2 Participants |
| Drug: Placebo | Number of Participants With Adverse Events | 6 Participants |