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The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental |
| |
| Treatment Group 2 | Experimental |
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| Treatment Group 3 | Experimental |
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| Treatment Group 4 | Active Comparator |
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| Treatment Group 5 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-555739 Dose 1 | Drug |
| ||
| S-555739 Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS) | Change from baseline through the 2-week treatment period (Day 2 through Day 15) | |
| Incidence of adverse events (AEs) | From Screening period to Week 6 (Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS) | Change from baseline through the 2-week treatment period (Day 2 through Day 15) | |
| Change in average AM/PM Total Ocular Symptom Score | Change from baseline through the 2-week treatment period (Day 2 through Day 15) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D015508 | Nasal Obstruction |
| D012912 | Sneezing |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Drug |
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| Cetirizine HCl Dose 1 | Drug |
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| S-555739 placebo | Drug |
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| Cetirizine HCl placebo | Drug |
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| Assessment of Quality of Life | Change from Week 3 to Week 5 |
| Assessment of vital signs | At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5 |
| Assessment of clinical laboratory parameters | At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up) |
| Assessment of electrocardiogram (ECG) findings | At Week 1 (Screening) and Week 5 |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |