The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.

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

Nasal Congestion

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.

Diphenhydramine 50 mg

Diphenhydramine 25 mg

Pseudoephedrine 120 mg

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

Benchmark Research - Austin

Allergy and Asthma Associates

Lovelace Scientific Resources

Allergy/Immunology Research Center of North Texas

Kerrville Research Associates

Central Texas Health Research

Benchmark Research - San Angelo

Sun Research Institute

Biogenics Research Institute

Diagnostics Research Group

Sylvana Research Associates

Allergy Asthma Research Institute

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?