NCT01119534

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

April 29, 2010

Last Update Submit

January 27, 2011

Conditions

Cough

Keywords

Cough treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Analysis of parameters for the improvement of infectious cough.

    7 days of treatment.

Study Arms (3)

Transpulmin

EXPERIMENTAL

Suppository composed by guaiacol, eucalyptol, menthol and camphor

Drug: Guaiacol, eucalyptol, menthol and camphor suppository

Comparator 1

ACTIVE COMPARATOR

Suppository composed by guaiacol

Drug: guaiacol suppository

Comparator 2

ACTIVE COMPARATOR

Syrup composed by guaifenesin

Drug: Guaifenesin syrup

Interventions

Guaiacol, eucalyptol, menthol and camphor suppositoryDRUG

2 times per day

Transpulmin
guaiacol suppositoryDRUG

2 times per day

Comparator 1
Guaifenesin syrupDRUG

4.19 mL - 4 in 4 hours

Comparator 2

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Conditions

Cough

Interventions

GuaiacolEucalyptolMenthol

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsPhenyl EthersCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCyclohexanolsHexanolsFatty AlcoholsAlcoholsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicMonoterpenesTerpenesLipidsCyclohexane Monoterpenes

Central Study Contacts

Alexandre Frederico, Physician

CONTACT

55 19 3829-3822alexandre@lalclinica.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 7, 2010

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

BR(1)