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This study is to evaluate the effectiveness of a new drug on congestion in subjects with seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant, pseudoephedrine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCH 900538 | Experimental |
| |
| Encapsulated pseudoephedrine | Active Comparator | Encapsulated pseudoephedrine (2X30 mg immediate release tablets) |
|
| Placebo Capsules | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 900538 | Drug | (4X50mg Capsules) |
| |
| Pseudoephedrine |
| Measure | Description | Time Frame |
|---|---|---|
| Average change from baseline in nasal congestion scores over the first 4-hour observation period. | Over the first 4-hour observation period. |
| Measure | Description | Time Frame |
|---|---|---|
| Average change from baseline in nasal congestion at each evaluation time point. | Over 12 hours. | |
| Average change from baseline in total symptoms, total symptoms minus congestion, total nasal symptoms, total nasal symptoms minus congestion, total non-nasal symptoms, and individual symptoms scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
Encapsulated pseudoephedrine (2X30 mg immediate release tablets) |
|
|
| Placebo Capsules | Drug | Placebo |
|
| Over the first 4 hour and 12-hour study periods. |
| Onset of action: defined as the first time point at which a sustained, statistically significant (P<=0.05) reduction relative to placebo in an efficacy variable (eg, nasal congestion) up to a pre-specified time point. | Over the first 4-hours and 12-hour study periods. |
| Average change from baseline in PNIF over the first 4-hour and 12-hour study periods and at each time point. | Over the first 4-hour and 12-hour study periods. |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020005 |
| Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |