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
Recruitment status was Not yet recruiting
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
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
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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:
MedlinePlus related topics:
Cough
Drug Information available for:
Camphor
Guaifenesin
Phenylpropanolamine hydrochloride
Eucalyptol
Menthol
Triaminic
Phenylpropanolamine
U.S. FDA Resources
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
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 June 18, 2013