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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03766373 |
Recruitment Status :
Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : February 4, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Otitis Media | Combination Product: Drug: OP0201 20mg Combination Product: Drug: Placebo 0mg | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media |
Actual Study Start Date : | January 7, 2019 |
Estimated Primary Completion Date : | February 2019 |
Estimated Study Completion Date : | February 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Drug: OP0201 |
Combination Product: Drug: OP0201 20mg
OP0201 |
Placebo Comparator: Drug: Placebo |
Combination Product: Drug: Placebo 0mg
Placebo |
- Safety (Evaluation of Adverse Events) [ Time Frame: 1 Day ]
- Ear Pain Reduction using the Visual Analog Scale (VAS) [ Time Frame: 1 Day ]The Visual Analog Scale (VAS) consists of a 100 mm line anchored by 2 extremes of pain (e.g., no pain versus worse pain). Subjects mark the line where their pain is best represented between the 2 anchors. Pain intensity scores are determined by the distance from the 'no pain' anchor to the subject's mark. Ear pain will be scored by the subjects separately for the left and right ear.
- Ear Pain Reduction using the Numeric Rating Scale (NRS-11) [ Time Frame: 1 Day ]The NRS requires that subjects select a whole number that best represents the intensity of their pain. On the NRS-11, pain scores range from 0 to 11, with 0 representing no pain and 10 representing the worst pain possible. Ear pain will be scored by the subjects separately for the left and right ear.
- Global impression of change in symptoms will be rated by the subject using the Patient Global Impression of Change (PGIC) [ Time Frame: 1 Day ]The PGIC is a questionnaire that asks the subject to assess the global change in health status since receiving the study drug. Scores on the PGIC range from 1 to 7 with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse
- The physician investigator will rate global impression of change post dose using Clinical Global Impressions Scale: Global Improvement (CGI I [ Time Frame: 1 day ]The CGI-I assesses the physician investigator's global impression of global change from baseline in symptoms since the administration of study drug. Scores range from 1 to 7, with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria includes but is not limited to:
- 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.
Exclusion Criteria includes but is not limited to:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766373
United States, California | |
US Clinical Research Group, LLC. | |
Bellflower, California, United States, 90706 | |
United States, Florida | |
Vista Health Research | |
Miami, Florida, United States, 33176 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Additional Information:
Responsible Party: | Novus Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT03766373 History of Changes |
Other Study ID Numbers: |
OP0201-C-004 |
First Posted: | December 6, 2018 Key Record Dates |
Last Update Posted: | February 4, 2019 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |