NCT00857987

Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.

Randomized , Placebo-controlled, Clinical Trial of Efficacy and Safety Evaluation of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improving the Signs and Symptoms of Infections of Way Upper (URI)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the improvement of the common cold with the use of medication

Detailed description

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: * Patients who have no clinical symptoms get high. * Patients who have not improved, take a dose of medicine increased. * The worsening of the present that, due to infections bacterial or other clinical pictures, will be excluded and referred to a general practitioner employed by the sponsor. In return for seven days, patients should return the products and again participate in a clinical consultation, in which researchers may take the following behaviors: * Patients who have no clinical symptoms get high. * Patients who have not improved or have worsened will be exempted from study and referred to the general practitioner hired by the sponsor is repeated for the diagnosis and establish a new treatment. Will be allowed the use of rescue medications such as paracetamol or sodium dipyrone, justified by the existence of the placebo group and those products do not interfere in the results evaluated, it was a pain and antipyretics.

Conditions

• Upper Airway Infections

Interventions

Type	Name	Description
DRUG	EMS Expectorant	Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.
OTHER	Placebo	Vehicle

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2009-03-09
• Last updated: 2011-01-28

Locations

1 site across 1 country: Brazil