Status:
UNKNOWN
Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.
Lead Sponsor:
Azidus Brasil
Conditions:
Upper Airway Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Patients who take part in the study, agreeing with the terms proposed in FICT;
- Patients aged 12 years or above of any ethnicity, class or social group;
- Patients of both sexes;
- Patients with good mental health;
- Patient with acute respiratory disease of the upper airways of viral etiology (URI);
- Patient with the early signs and symptoms of URI with minimum time of failure greater than 48 hours.
Exclusion
- Patients treated with antibiotics or predict the use of antibiotics for other clinical condition;
- Presence of bacterial tables of the upper airways and lungs (bacterial sinusitis, pneumonia, etc.).
- Patient with cystic fibrosis;
- Primary or metastatic cancer to the lung;
- Presence of respiratory tables with more than 14 days in duration;
- Treatment with immunosuppressive drugs;
- Presence of any medical or psychological condition that, at the discretion of the investigator, should prevent the patient from the study;
- History of abuse of alcohol or drugs;
- Participation in clinical trials in the six months preceding the study;
- Patients with severe pulmonary diseases, which require multi-drug treatment;
- Presence of other concomitant pulmonary diseases;
- Pregnancy and lactation;
- History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00857987
Start Date
April 1 2010
End Date
December 1 2011
Last Update
January 28 2011
Active Locations (1)
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1
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270000