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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Diphenhydramine 50 mg |
|
| 2 | Experimental | Diphenhydramine 25 mg |
|
| 3 | Active Comparator | Pseudoephedrine 120 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphenhydramine 50 mg | Drug | Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Israel, BS | McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benchmark Research - Austin | Austin | Texas | 78705 | United States | ||
| Allergy and Asthma Associates |
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| Diphenhydramine 25 mg | Drug | Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet |
|
|
| Pseudoephedrine 120 mg | Drug | Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet |
|
|
| 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 |
| Austin |
| Texas |
| 78731 |
| United States |
| Lovelace Scientific Resources | Austin | Texas | 78759 | United States |
| Allergy/Immunology Research Center of North Texas | Dallas | Texas | 75230 | United States |
| Kerrville Research Associates | Kerrville | Texas | 78028 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Benchmark Research - San Angelo | San Angelo | Texas | 76904 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| Biogenics Research Institute | San Antonio | Texas | 78229 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Sylvana Research Associates | San Antonio | Texas | 78229 | United States |
| Allergy Asthma Research Institute | Waco | Texas | 76712 | United States |
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D010627 | Phenethylamines |
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