CoughPhase 3NCT01119534
Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin
A Phase 3 study testing Guaiacol, eucalyptol, menthol and camphor suppository, guaiacol suppository and Guaifenesin syrup in people with Cough, run by Azidus Brasil at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Cough
- What is being tested?
- Guaiacol, eucalyptol, menthol and camphor suppository, guaiacol suppository and Guaifenesin syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
Alexandre Frederico, Physician, 55 19 3829-3822, alexandre@lalclinica.com.br
About this study
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
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
- Being tested
- Guaiacol, eucalyptol, menthol and camphor suppository, guaiacol suppository, Guaifenesin syrup
- Keywords
- Cough treatment
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guaiacol, eucalyptol, menthol and camphor suppositoryDrug
2 times per day
guaiacol suppositoryDrug
2 times per day
Guaifenesin syrupDrug
4.19 mL - 4 in 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Transpulmin | Experimental | Suppository composed by guaiacol, eucalyptol, menthol and camphor Receives: Drug: Guaiacol, eucalyptol, menthol and camphor suppository |
| Comparator 1 | Active comparator | Suppository composed by guaiacol Receives: Drug: guaiacol suppository |
| Comparator 2 | Active comparator | Syrup composed by guaifenesin Receives: Drug: Guaifenesin syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days of treatment.
Secondary outcomes (1)
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.
Measured: 7 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMay 2011
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119534
- Sponsor's protocol ID
- ACH-TRN-03(01/10)
- Other IDs
- Version 05 - March 9, 2010
- Status last verified
- Jan 2011
- First submitted
- 29 Apr 2010
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01119534
- Acronym / sponsor ID
- ACH-TRN-03(01/10)
- Conditions
- Cough
- Keywords
- Cough treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transpulmin | Experimental | Drug: Guaiacol, eucalyptol, menthol and camphor suppositorySuppository composed by guaiacol, eucalyptol, menthol and camphor |
| Comparator 1 | Active comparator | Drug: guaiacol suppositorySuppository composed by guaiacol |
| Comparator 2 | Active comparator | Drug: Guaifenesin syrupSyrup composed by guaifenesin |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guaiacol, eucalyptol, menthol and camphor suppository2 times per day | Drug | Transpulmin |
| guaiacol suppository2 times per day | Drug | Comparator 1 |
| Guaifenesin syrup4.19 mL - 4 in 4 hours | Drug | Comparator 2 |
Primary outcome
Improvement of cough of infectious origin.
Time frame: 7 days of treatment.
During visits (V1, V2, V3 and V4) will be assessed the signs of improvement of cough of infectious origin.
1 secondary outcome
Analysis of parameters for the improvement of infectious cough.
Time frame: 7 days of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guaiacol, eucalyptol, menthol and camphor suppository, guaiacol suppository and Guaifenesin syrup in people with Cough, run by Azidus Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Frederico, Physician (55 19 3829-3822, alexandre@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of cough of infectious origin. (time frame: 7 days of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.