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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2019-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Performance and Safety of Otinova® Ear Spray

NCT05370209

Otitis Externa

TERMINATED NA

Study to Compare Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media (AR01007)

NCT02074007

Acute Otitis Media

TERMINATED PHASE3

Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.

NCT00967317

Otitis Efficacy Tolerability

UNKNOWN PHASE3

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

NCT03534219

Recurrent Acute Otitis Media Acute Otitis Media

WITHDRAWN NA

Vaccination for Middle Ear Infection

NCT00001605

Otitis Media

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Otitis Media

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug: OP0201

Group Type ACTIVE_COMPARATOR

Drug: OP0201 20mg

Intervention Type COMBINATION_PRODUCT

OP0201

Drug: Placebo

Group Type PLACEBO_COMPARATOR

Drug: Placebo 0mg

Intervention Type COMBINATION_PRODUCT

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drug: OP0201 20mg

OP0201

Intervention Type COMBINATION_PRODUCT

Drug: Placebo 0mg

Placebo

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No