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| ID | Type | Description | Link |
|---|---|---|---|
| GADEMS0109 |
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Evaluate the improvement of the common cold with the use of medication
Patients with signs and symptoms of URI will be forwarded to the Research Center for a screening in which the researchers will select those meet the inclusion criteria. This visit will be informed of the objectives study, methodology, risks and benefits, the right of patients to give up research, the confidentiality of data and other details that provide the the patients to consider their participation basement viable or not. All aspects relevant to the consideration of the patient on their participation will described in the Informed Consent, which will be read and signed before any procedure. The patients included are randomized, open treatment immediately and will be sent to perform a radiological examination (Rx - sinus of the face). This examination used to detect other clinical pictures than URI. After 24 hours (visit 02), the patient will return for the assessment and clinical questions about their symptoms, which provide the scores of efficacy of the product. This visit will review the radiological examination, and on the finding that infection of sinuses without symptoms, the patient will excluded because of antibiotic use will begin. In return for three days (visit 03), patients will again evaluated in relation to their clinical status. On this visit, the doctor may take the following behaviors:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Guaifenesin, doxylamine succinate and hydrochloride etafedrine syrup |
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| 2 | Placebo Comparator | Vehicle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMS Expectorant | Drug | Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| - Decrease in nasal secretion - Decrease in sneezing - Reduction of edema of the nasal mucosa - Decreased frequency of cough - Decrease the frequency of dyspnea - Reduction of nasal obstruction | Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2) |
| Measure | Description | Time Frame |
|---|---|---|
| Will be assessed for safety by the incidence of adverse reactions | Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karina Guerra, Coordinator | Contact | 55 19 3829-3822 | karina@lalclinica.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clinica Pesquisa e Desenvolvimento Ltda | Recruiting | Valinhos | São Paulo | 13270000 | Brazil |
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| Placebo |
| Other |
Vehicle |
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