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

NCT ID: NCT01119534

Last Updated: 2011-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-12-31

Brief 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.

Conditions

Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transpulmin

Suppository composed by guaiacol, eucalyptol, menthol and camphor

Group Type: EXPERIMENTAL

Guaiacol, eucalyptol, menthol and camphor suppository

Intervention Type: DRUG

2 times per day

Comparator 1

Suppository composed by guaiacol

Group Type: ACTIVE_COMPARATOR

guaiacol suppository

Intervention Type: DRUG

2 times per day

Comparator 2

Syrup composed by guaifenesin

Group Type: ACTIVE_COMPARATOR

Guaifenesin syrup

Intervention Type: DRUG

4.19 mL - 4 in 4 hours

Interventions

Guaiacol, eucalyptol, menthol and camphor suppository

2 times per day

Intervention Type: DRUG

guaiacol suppository

2 times per day

Intervention Type: DRUG

Guaifenesin syrup

4.19 mL - 4 in 4 hours

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clinica Pesquisa e Desenvolvimento Ltda

Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Central Contacts

Alexandre Frederico, Physician

Role: CONTACT

alexandre@lalclinica.com.br

55 19 3829-3822

Facility Contacts

Alexandre Frederico, Physician

Role: primary

alexandre@lalclinica.com.br

55 19 3829-3822

Other Identifiers

Version 05 - March 9, 2010

Identifier Type: -

Identifier Source: secondary_id

ACH-TRN-03(01/10)

Identifier Type: -

Identifier Source: org_study_id