Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

Cough Clinical Trial

Official title:

Comparative Efficacy of the Suppository Composed by Guaiacol, Eucalyptol, Menthol and Camphor Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01119534
• Other study ID #: ACH-TRN-03(01/10)
• Secondary ID: Version 05 - Mar
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 29, 2010
• Last updated: January 27, 2011
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2011
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: Alexandre Frederico, Physician
• Phone: 55 19 3829-3822
• Email: alexandre[@]lalclinica.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Patients that parents or legal guardians agree to their participation in the study and agree on the terms proposed in the IC, signing it;

• Patients aged = (greater than or equal to) 02 years and = (less than or equal to) 6 years, 11 months and 29 days, of any ethnicity, class or social group.

• Patients with acute respiratory disease of upper respiratory viral diseases (URI);

• Patients with productive cough;

• Clinical picture of URI defined by the doctor that started less than 48 hours.

Exclusion Criteria:

• Patients being treated with antibiotics;

• Presence of clinical features of bacterial infection of the upper airways and / or pulmonary (acute bacterial sinusitis, pneumonia, etc.).

• Patients with non-productive cough;

• Treatment with immunosuppressive drugs;

• Presence of any medical condition that, according to the investigator, should prevent the patient from the study;

• Participation in clinical trials in the 12 months preceding the study, according to Resolution 251 (ANVISA), August 7, 1997, item III, sub-item J;

• Patients with serious diseases;

• Patients who require multidrug treatment;

• Presence of other concomitant pulmonary diseases

• History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;

• Patients with diseases that interfere with lung function, such as cerebral palsy or muscular atrophies;

• Patients under medication or supplement (eg physiotherapy) that may interfere with the cough;

• Patients with severe dysfunction of the hepatorenal function;

• Patients with x-ray of the chest or sinus compatible with picture of bacterial infection;

• Patients with blood cell count suggestive of bacterial infection;

• Changes in laboratory, clinical, physical and / or radiological agents that, judged by investigators, could compromise patient health or reliability of the data.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Guaiacol, eucalyptol, menthol and camphor suppository
2 times per day
• guaiacol suppository
2 times per day
• Guaifenesin syrup
4.19 mL - 4 in 4 hours

Locations

Country	Name	City	State
Brazil	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of cough of infectious origin.	During visits (V1, V2, V3 and V4) will be assessed the signs of improvement of cough of infectious origin.	7 days of treatment.	No
Secondary	Analysis of parameters for the improvement of infectious cough.	During visits (V1, V2, V3 and V4) will be assessed the signs of improvement in difficulty in breathing,quality of sleep,nasal obstruction, food intake and adherence to the treatment.	7 days of treatment.	No