A Phase 4 interventional study of Diphenhydramine 50 mg and Diphenhydramine 25 mg in Nasal Congestion, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide. Completed at 12 sites in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-08-22.
Sponsored by Johnson & Johnson Consumer and Personal Products Worldwide · Phase 4, Interventional, and Treatment
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.
392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.
This study's enrollment of 1,021 is above the median of 136 across 356 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Johnson & Johnson Consumer and Personal Products Worldwide is the lead sponsor of 58 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diphenhydramine 50 mg
Drug: Diphenhydramine 50 mg
Diphenhydramine 25 mg
Drug: Diphenhydramine 25 mg
Pseudoephedrine 120 mg
Drug: Pseudoephedrine 120 mg
Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet
Also known as: Active: Lot # 070PB6 Formula # W015990-0002
Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet
Also known as: Active: Lot # 070PB6 Formula # W015990-0002
Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet
Also known as: Active: Lot # INT-06-115 Formula # W015721-0004
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
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
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
Duration of action for diphenhydramine for treatment of nasal congestion/stuffiness was evaluated by comparing the change from baseline in the subject's mean instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo
Time frame: taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)
Duration of action for diphenhydramine for treatment of allergic rhinitis symptoms was evaluated by comparing the change from baseline in the subject's mean instantaneous TNS scores for diphenhydramine versus placebo
Time frame: taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)
Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints
Time frame: 14 Days
Subject's global evaluation of response to treatment
Time frame: at Visits 3 and 4, analyzed separately at each visit
Change from baseline in the Investigator's TNS score
Time frame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
Change from baseline in the Investigator's TSS score
Time frame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
Change from baseline for each of the eight individual Investigator's SAR symptoms
Time frame: at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1
Investigator's global evaluation of the subject's response to treatment
Time frame: at Visits 3 and 4, analyzed separately for each visit
Number and percentage of subjects experiencing adverse events
Time frame: Duration of study
Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate)
Time frame: Duration of study
Occurrence of somnolence
Time frame: Overall and weekly
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer and Personal Products Worldwide