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

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Congestion
• Rhinitis, Allergic, Seasonal

• NCT number: NCT00648973
• Study type: Interventional
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Completion date: May 2007