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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01119534
First received: April 29, 2010
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Cough
Drug: Guaiacol, eucalyptol, menthol and camphor suppository
Drug: guaiacol suppository
Drug: Guaifenesin syrup
Phase 3

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

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Improvement of cough of infectious origin. [ Time Frame: 7 days of treatment. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 7 days of treatment. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 270
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transpulmin
Suppository composed by guaiacol, eucalyptol, menthol and camphor
Drug: Guaiacol, eucalyptol, menthol and camphor suppository
2 times per day
Active Comparator: Comparator 1
Suppository composed by guaiacol
Drug: guaiacol suppository
2 times per day
Active Comparator: Comparator 2
Syrup composed by guaifenesin
Drug: Guaifenesin syrup
4.19 mL - 4 in 4 hours

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119534

Contacts
Contact: Alexandre Frederico, Physician 55 19 3829-3822 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, SP, Brazil, 13270000
Contact: Alexandre Frederico, Physician    55 19 3829-3822    alexandre@lalclinica.com.br   
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Dr. Jose Espin Neto, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01119534     History of Changes
Other Study ID Numbers: ACH-TRN-03(01/10), Version 05 - March 9, 2010
Study First Received: April 29, 2010
Last Updated: January 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Cough treatment

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Camphor
Cineole
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Menthol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants

ClinicalTrials.gov processed this record on July 20, 2014