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

Primary Purpose

Cough

Status

Unknown status

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Guaiacol, eucalyptol, menthol and camphor suppository

guaiacol suppository

Guaifenesin syrup

About this trial

This is an interventional treatment trial for Cough focused on measuring Cough treatment

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Transpulmin

Comparator 1

Comparator 2

Arm Description

Suppository composed by guaiacol, eucalyptol, menthol and camphor

Suppository composed by guaiacol

Syrup composed by guaifenesin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01119534

First Posted

April 29, 2010

Last Updated

January 27, 2011

Sponsor

Azidus Brasil

1. Study Identification

Unique Protocol Identification Number

NCT01119534

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Azidus Brasil

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cough

Keywords

Cough treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transpulmin

Arm Type

Experimental

Arm Description

Suppository composed by guaiacol, eucalyptol, menthol and camphor

Arm Title

Comparator 1

Arm Type

Active Comparator

Arm Description

Suppository composed by guaiacol

Arm Title

Comparator 2

Arm Type

Active Comparator

Arm Description

Syrup composed by guaifenesin

Intervention Type

Drug

Intervention Name(s)

Guaiacol, eucalyptol, menthol and camphor suppository

Intervention Description

2 times per day

Intervention Type

Drug

Intervention Name(s)

guaiacol suppository

Intervention Description

2 times per day

Intervention Type

Drug

Intervention Name(s)

Guaifenesin syrup

Intervention Description

4.19 mL - 4 in 4 hours

Primary Outcome Measure Information:

Title

Improvement of cough of infectious origin.

Description

During visits (V1, V2, V3 and V4) will be assessed the signs of improvement of cough of infectious origin.

Time Frame

7 days of treatment.

Secondary Outcome Measure Information:

Title

Analysis of parameters for the improvement of infectious cough.

Description

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.

Time Frame

7 days of treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandre Frederico, Physician

Phone

55 19 3829-3822

alexandre@lalclinica.com.br

Facility Information:

Facility Name

LAL Clínica Pesquisa e Desenvolvimento Ltda

City

Valinhos

State/Province

ZIP/Postal Code

13270000

Country

Brazil

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandre Frederico, Physician

Phone

55 19 3829-3822

alexandre@lalclinica.com.br

12. IPD Sharing Statement

Learn more about this trial

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

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