To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses

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.

Inclusion Criteria:

• otherwise healthy males and females
• 12 to 65 years of age
• hypersensitivity to specific pollens for a minimum of 2 years prior to study start
• appropriate SAR sign/symptoms scores

Exclusion Criteria:

• pregnancy, lactation and contraception issues
• contraindicated medications or therapies
• evidence of clinical, dietary, lifestyle or psychiatric issues, which in the opinion of the investigator, could increase the risk to the subject or research staff, or interfere with the interpretation of study results