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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

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ClinicalTrials.gov Identifier: NCT03766373
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

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

Condition or disease Intervention/treatment Phase
Acute Otitis Media Combination Product: Drug: OP0201 20mg Combination Product: Drug: Placebo 0mg Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Drug: OP0201 Combination Product: Drug: OP0201 20mg
OP0201
Placebo Comparator: Drug: Placebo Combination Product: Drug: Placebo 0mg
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety (Evaluation of Adverse Events) [ Time Frame: 1 Day ]

Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Novus Therapeutics, Inc
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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