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The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.
Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naridrin | Experimental | Naridrin: 2 drops in each nostril once daily as prescription |
|
| 0.05 % Oxymetazoline Hydrochloride | Active Comparator | 2 pumps in each nostril every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naridrin | Drug | Naridrin® : 2 drops in each nostril once daily as prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief of Nasal Congestion | Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion) | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety of the drug will be assessed by observation of adverse events monitored for the type, frequency and intensity during the days of the follow-up. The evaluation of the heart frequency will also be a safety parameter. | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina do ABC | Santo André | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D009278 | Naphazoline |
| D011738 | Pyrilamine |
| C007288 | dexpanthenol |
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Afrin | Drug | 2 pumps in each nostril every 12 hours. |
|
|
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D000631 |
| Aminopyridines |
| D011725 | Pyridines |