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

Acute Otitis Media Clinical Trial

Official title:

Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766373
• Other study ID #: OP0201-C-004
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2019
• Est. completion date: January 30, 2019

Study information

• Verified date: October 2019
• Source: Novus Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Combination Product:
• Drug: OP0201 20mg
OP0201
• Drug: Placebo 0mg
Placebo

Locations

Country	Name	City	State
United States	US Clinical Research Group, LLC.	Bellflower	California
United States	Vista Health Research	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novus Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		1 Day

External Links

•   Link