Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY X002134 | Experimental | Subjects will be given BAY X002134 |
|
| Placebo | Placebo Comparator | Subjects will be given a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorpheniramine maleate (BAY X002134) | Drug | 4 mg tablet, single dose, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS) | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events as a measure of safety | 3 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germantown | Tennessee | 38138 | United States |
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D002744 | Chlorpheniramine |
| ID | Term |
|---|---|
| D010632 | Pheniramine |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
placebo tablet, single dose, orally |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |