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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Nasal Congestion

Intervention / Treatment
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* Drug: Diphenhydramine 50 mg
* Drug: Diphenhydramine 25 mg
* Drug: Pseudoephedrine 120 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Diphenhydramine 50 mg | Drug: Diphenhydramine 50 mg<br>* Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet<br>* Other names: Active: Lot # 070PB6 Formula # W015990-0002;|
| Experimental: 2<br>Diphenhydramine 25 mg | Drug: Diphenhydramine 25 mg<br>* Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet<br>* Other names: Active: Lot # 070PB6 Formula # W015990-0002;|
| Active Comparator: 3<br>Pseudoephedrine 120 mg | Drug: Pseudoephedrine 120 mg<br>* Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet<br>* Other names: Active: Lot # INT-06-115 Formula # W015721-0004;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score |  | every 12-hours over the 14-day treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score |  | 14 Days | 
| Change from baseline in the subject's mean instantaneous TNS Score |  | 14 Days | 
| Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score |  | 14 Days | 
| Change from baseline in the subject's mean instantaneous TSS Score |  | 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 |  | 14 Days | 
| Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | 14 Days | 
| Subject's global evaluation of response to treatment |  | at Visits 3 and 4, analyzed separately at each visit | 
| Change from baseline in the Investigator's TNS score |  | 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 |  | 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 |  | 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 |  | at Visits 3 and 4, analyzed separately for each visit | 
| Number and percentage of subjects experiencing adverse events |  | Duration of study | 
| Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate) |  | Duration of study | 
| Occurrence of somnolence |  | Overall and weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal Allergic Rhinitis, nasal congestion