Nasal Congestion Clinical Trial
Official title:
Evaluation of Nasal Congestion Clinical Efficacy for Diphenhydramine 25 mg and Diphenhydramine 50 mg in Seasonal Allergic Rhinitis: a Randomized, Double-blind, Placebo and Pseudoephedrine Controlled Study
The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.
Subjects who met the inclusion/exclusion criteria were enrolled into the placebo run-in
phase of the study on Day -7 (prerandomization, Visit 1). Baseline symptom scores were
established during this run-in phase.
Subjects with moderate nasal congestion who took at least 80% of their study medication
during the run-in phase were eligible for enrollment in the two-week double-blind phase of
the study and were randomized on Day 1 (randomization, Visit 2). They were treated for two
weeks with their assigned medication. The severity of signs/symptoms were evaluated by the
subjects every morning and night and by the investigator at each visit on Day 7 and Day 14.
In addition, the subject and investigator provided a global evaluation of response to
treatment on Day 7 and Day 14. Safety was evaluated by adverse events reported during the
study, vital signs, and the incidence of somnolence.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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