Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Status and phase
Completed
Phase 2
Conditions
Seasonal Allergic Rhinitis
Treatments
Drug: Placebo Nasal Spray
Drug: Bepotastine Besilate Nasal Spray 2% Twice a day
Drug: Bepotastine Besilate Nasal Spray 3% Twice a day
Drug: Bepotastine Besilate Nasal Spray 4% Twice a day
Details and patient eligibility
About
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
Enrollment
601 patients
Sex
All
Ages
12+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male or female at least 12 years of age with a history of mountain cedar allergy
Exclusion criteria
- No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
601 participants in 4 patient groups, including a placebo group
2% Twice a day
Experimental group
Description:
Bepotastine Besilate Nasal Spray 2% Twice a day
Treatment:
Drug: Bepotastine Besilate Nasal Spray 2% Twice a day
3% Twice a day
Experimental group
Description:
Bepotastine Besilate Nasal Spray 3% Twice a day
Treatment:
Drug: Bepotastine Besilate Nasal Spray 3% Twice a day
4% Twice a day
Experimental group
Description:
Bepotastine Besilate Nasal Spray 4% Twice a day
Treatment:
Drug: Bepotastine Besilate Nasal Spray 4% Twice a day
Placebo
Placebo Comparator group
Description:
Placebo nasal spray
Treatment:
Drug: Placebo Nasal Spray
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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