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

Johnson & Johnson Consumer and Personal Products Worldwide1,021 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,021

Conditions

Nasal Congestion

Interventions

Diphenhydramine 50 mgDRUG

Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet

Diphenhydramine 25 mgDRUG

Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet

Pseudoephedrine 120 mgDRUG

Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (12)

Benchmark Research - Austin

Austin, Texas, United States

Allergy and Asthma Associates

Austin, Texas, United States

Lovelace Scientific Resources

Austin, Texas, United States

Outcomes

Primary Outcomes

Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score

Time frame: every 12-hours over the 14-day treatment period

Secondary Outcomes

Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score

Time frame: 14 Days

Change from baseline in the subject's mean instantaneous TNS Score

Time frame: 14 Days

Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score

Time frame: 14 Days

Change from baseline in the subject's mean instantaneous TSS Score

Time frame: 14 Days

Change from baseline in the subject's mean reflective score for each of the seven remaining individual SAR symptoms, excluding nasal congestion/stuffiness

Time frame: 14 Days

Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms

Time frame: 14 Days

Onset of action for diphenhydramine treatment for nasal congestion/stuffiness was determined by comparing the change from baseline in the subject's instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo

Time frame: taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose.

Onset of action for diphenhydramine treatment for allergic rhinitis symptoms was determined by comparing the change from baseline in the subject's instantaneous TNS scores for diphenhydramine versus placebo

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.