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| ID | Type | Description | Link |
|---|---|---|---|
| Version 3, Amendment 1 |
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The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.
Secondly, it will be observed safety (tolerability) clinic after the administration of the drug in patients by comparing the clinical parameters and the incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (Cloratadd D) | Experimental | Loratadine + Pseudoephedrine sulfate Test |
|
| Comparator (Claritin D) | Active Comparator | Loratadine + Pseudoephedrine Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loratadine + Pseudoephedrine sulfate | Drug | Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical signs and symptoms and nasal flow | 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Avaliation of Safety through the adverse affects observation | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL ClÃnica Pesquisa e Desenvolvimento Ltda | Valinhos | São Paulo | 13276245 | Brazil |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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