Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857987
Recruitment Status : Unknown
Verified January 2011 by Azidus Brasil.
Recruitment status was:  Recruiting
First Posted : March 9, 2009
Last Update Posted : January 28, 2011
Information provided by:
Azidus Brasil

Brief Summary:
Evaluate the improvement of the common cold with the use of medication

Condition or disease Intervention/treatment Phase
Upper Airway Infections Drug: EMS Expectorant Other: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: 1
Guaifenesin, doxylamine succinate and hydrochloride etafedrine syrup
Drug: EMS Expectorant
Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.

Placebo Comparator: 2
Other: Placebo

Primary Outcome Measures :
  1. - 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 [ Time Frame: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2) ]

Secondary Outcome Measures :
  1. Will be assessed for safety by the incidence of adverse reactions [ Time Frame: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857987

Layout table for location contacts
Contact: Karina Guerra, Coordinator 55 19 3829-3822

Layout table for location information
LAL Clinica Pesquisa e Desenvolvimento Ltda Recruiting
Valinhos, SP, Brazil, 13270000
Contact: Karina Guerra, Coordinator    55 19 3829 3822   
Principal Investigator: Alexandre Frederico, Doctor         
Sponsors and Collaborators
Azidus Brasil
Layout table for additonal information
Responsible Party: Alexandre Frederico, LAL Clinica Identifier: NCT00857987    
Other Study ID Numbers: GADEMS0109
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011
Keywords provided by Azidus Brasil:
IRA, Guaifenesin, Etaphedrine, Doxilamine
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Respiratory System Agents