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Antibiotic
Drug: OP0201 + Antibiotics for Ear Infection
Phase 2
Waitlist Available
Research Sponsored by Novus Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.
Eligible Conditions
- Ear Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluation of Efficacy (Otoscopy)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Drug: OP0201 + AntibioticsActive Control2 Interventions
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Group II: Placebo Comparator: Placebo +AntibioticsPlacebo Group2 Interventions
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
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Who is running the clinical trial?
Novus Therapeutics, IncLead Sponsor
5 Previous Clinical Trials
1,150 Total Patients Enrolled
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