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

NCT03766373 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: OP0201-C-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  1 Day

Study Arms (2)

Drug: OP0201

ACTIVE COMPARATOR

Combination Product: Drug: OP0201 20mg

Drug: Placebo

PLACEBO COMPARATOR

Combination Product: Drug: Placebo 0mg

Interventions

Drug: OP0201 20mg COMBINATION_PRODUCT

OP0201

Drug: OP0201

Drug: Placebo 0mg COMBINATION_PRODUCT

Placebo

Drug: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novus Therapeutics, Inc: lead

Study Sites (2)

US Clinical Research Group, LLC.

Bellflower, California, 90706, United States

Location

Vista Health Research

Miami, Florida, 33176, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Clinical Director
• Organization: Novus Therapeutics

study004@novustherapeutics.com

949-679-1110

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 6, 2018
• Study Start: January 7, 2019
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: December 5, 2019
• Results First Posted: November 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)