NCT00648973

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,021 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Nasal Congestion

Interventions

Type	Name	Description
DRUG	Diphenhydramine 50 mg	Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet
DRUG	Diphenhydramine 25 mg	Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet
DRUG	Pseudoephedrine 120 mg	Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2008-04-01
• Last updated: 2011-08-22

Locations

12 sites across 1 country: United States