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Antihistamine
A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies
Phase 3
Waitlist Available
Research Sponsored by Meda Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Summary
The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.
Eligible Conditions
- Hay Fever
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: MP03-36 Nasal SprayActive Control1 Intervention
azelastine hydrochloride 0.15%
Group II: MP03-36 and Placebo Nasal SprayActive Control1 Intervention
azelastine hydrochloride 0.15% and Placebo
Group III: Azelastine 0.1%, Nasal SprayActive Control1 Intervention
Azelastine 0.1%, Nasal Spray
Group IV: Placebo Nasal SaprayPlacebo Group3 Interventions
0mg, 2 sprays per nostril twice daily AM \& PM)
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Who is running the clinical trial?
Meda PharmaceuticalsLead Sponsor
22 Previous Clinical Trials
33,527 Total Patients Enrolled