Upper Airway InfectionsPhase 3NCT00857987
Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.
A Phase 3 study testing EMS Expectorant in people with Upper Airway Infections, run by Azidus Brasil at 1 site in Brazil.
Trial summary
Evaluate the improvement of the common cold with the use of medication Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Upper Airway Infections
- What is being tested?
- EMS Expectorant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who take part in the study, agreeing with the terms proposed in FICT;
- Patients aged 12 years or above of any ethnicity, class or social group;
- Patients of both sexes;
- Patients with good mental health;
- Patient with acute respiratory disease of the upper airways of viral etiology (URI);
- Patient with the early signs and symptoms of URI with minimum time of failure greater than 48 hours.
Who cannot join
- Patients treated with antibiotics or predict the use of antibiotics for other clinical condition;
- Presence of bacterial tables of the upper airways and lungs (bacterial sinusitis, pneumonia, etc.).
- Patient with cystic fibrosis;
- Primary or metastatic cancer to the lung;
- Presence of respiratory tables with more than 14 days in duration;
- Treatment with immunosuppressive drugs;
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- Presence of any medical or psychological condition that, at the discretion of the investigator, should prevent the patient from the study;
- History of abuse of alcohol or drugs;
- Participation in clinical trials in the six months preceding the study;
- Patients with severe pulmonary diseases, which require multi-drug treatment;
- Presence of other concomitant pulmonary diseases;
- Pregnancy and lactation;
- History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
Karina Guerra, Coordinator, 55 19 3829 3822, karina@lalclinica.com.br
Alexandre Frederico, Doctor
About this study
Official title: Randomized , Placebo-controlled, Clinical Trial of Efficacy and Safety Evaluation of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improving the Signs and Symptoms of Infections of Way Upper (URI)
Evaluate the improvement of the common cold with the use of medication
Read the detailed description
Patients with signs and symptoms of URI will be forwarded to the Research Center for a screening in which the researchers will select those meet the inclusion criteria. This visit will be informed of the objectives study, methodology, risks and benefits, the right of patients to give up research, the confidentiality of data and other details that provide the the patients to consider their participation basement viable or not. All aspects relevant to the consideration of the patient on their participation will described in the Informed Consent, which will be read and signed before any procedure. The patients included are randomized, open treatment immediately and will be sent to perform a radiological examination (Rx - sinus of the face). This examination used to detect other clinical pictures than URI. After 24 hours (visit 02), the patient will return for the assessment and clinical questions about their symptoms, which provide the scores of efficacy of the product. This visit will review the radiological examination, and on the finding that infection of sinuses without symptoms, the patient will excluded because of antibiotic use will begin. In return for three days (visit 03), patients will again evaluated in relation to their clinical status. On this visit, the doctor may take the following behaviors:
- Patients who have no clinical symptoms get high.
- Patients who have not improved, take a dose of medicine increased.
- The worsening of the present that, due to infections bacterial or other clinical pictures, will be excluded and referred to a general practitioner employed by the sponsor. In return for seven days, patients should return the products and again participate in a clinical consultation, in which researchers may take the following behaviors:
- Patients who have no clinical symptoms get high.
- Patients who have not improved or have worsened will be exempted from study and referred to the general practitioner hired by the sponsor is repeated for the diagnosis and establish a new treatment. Will be allowed the use of rescue medications such as paracetamol or sodium dipyrone, justified by the existence of the placebo group and those products do not interfere in the results evaluated, it was a pain and antipyretics.
- Conditions
- Upper Airway Infections
- Being tested
- EMS Expectorant, Placebo
- Keywords
- IRA, Guaifenesin, Etaphedrine, Doxilamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS ExpectorantDrug
Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.
PlaceboOther
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Guaifenesin, doxylamine succinate and hydrochloride etafedrine syrup Receives: Drug: EMS Expectorant |
| 2 | Placebo comparator | Vehicle Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Decrease in nasal secretion - Decrease in sneezing - Reduction of edema of the nasal mucosa - Decreased frequency of cough - Decrease the frequency of dyspnea - Reduction of nasal obstruction
Measured: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)
Secondary outcomes (1)
Will be assessed for safety by the incidence of adverse reactions
Measured: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startApr 2010
- 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 Upper Airway InfectionsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857987
- Sponsor's protocol ID
- GADEMS0109
- Other IDs
- GADEMS0109
- Status last verified
- Jan 2011
- First submitted
- 6 Mar 2009
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
- Randomized , Placebo-controlled, Clinical Trial of Efficacy and Safety Evaluation of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improving the Signs and Symptoms of Infections of Way Upper (URI)
- ClinicalTrials.gov ID
- NCT00857987
- Acronym / sponsor ID
- GADEMS0109
- Conditions
- Upper Airway Infections
- Keywords
- IRA, Guaifenesin, Etaphedrine, Doxilamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Mar 2009 (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.
Evaluate the improvement of the common cold with the use of medication
Detailed description
Patients with signs and symptoms of URI will be forwarded to the Research Center for a screening in which the researchers will select those meet the inclusion criteria. This visit will be informed of the objectives study, methodology, risks and benefits, the right of patients to give up research, the confidentiality of data and other details that provide the the patients to consider their participation basement viable or not. All aspects relevant to the consideration of the patient on their participation will described in the Informed Consent, which will be read and signed before any procedure. The patients included are randomized, open treatment immediately and will be sent to perform a radiological examination (Rx - sinus of the face). This examination used to detect other clinical pictures than URI. After 24 hours (visit 02), the patient will return for the assessment and clinical questions about their symptoms, which provide the scores of efficacy of the product. This visit will review the radiological examination, and on the finding that infection of sinuses without symptoms, the patient will excluded because of antibiotic use will begin. In return for three days (visit 03), patients will again evaluated in relation to their clinical status. On this visit, the doctor may take the following behaviors:
- Patients who have no clinical symptoms get high.
- Patients who have not improved, take a dose of medicine increased.
- The worsening of the present that, due to infections bacterial or other clinical pictures, will be excluded and referred to a general practitioner employed by the sponsor. In return for seven days, patients should return the products and again participate in a clinical consultation, in which researchers may take the following behaviors:
- Patients who have no clinical symptoms get high.
- Patients who have not improved or have worsened will be exempted from study and referred to the general practitioner hired by the sponsor is repeated for the diagnosis and establish a new treatment. Will be allowed the use of rescue medications such as paracetamol or sodium dipyrone, justified by the existence of the placebo group and those products do not interfere in the results evaluated, it was a pain and antipyretics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EMS ExpectorantGuaifenesin, doxylamine succinate and hydrochloride etafedrine syrup |
| 2 | Placebo comparator | Other: PlaceboVehicle |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who take part in the study, agreeing with the terms proposed in FICT;
- Patients aged 12 years or above of any ethnicity, class or social group;
- Patients of both sexes;
- Patients with good mental health;
- Patient with acute respiratory disease of the upper airways of viral etiology (URI);
Key exclusion criteria (13 listed)
- Patients treated with antibiotics or predict the use of antibiotics for other clinical condition;
- Presence of bacterial tables of the upper airways and lungs (bacterial sinusitis, pneumonia, etc.).
- Patient with cystic fibrosis;
- Primary or metastatic cancer to the lung;
- Presence of respiratory tables with more than 14 days in duration;
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 |
|---|---|---|
| EMS ExpectorantGuaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg. | Drug | 1 |
| PlaceboVehicle | Other | 2 |
Primary outcome
- Decrease in nasal secretion - Decrease in sneezing - Reduction of edema of the nasal mucosa - Decreased frequency of cough - Decrease the frequency of dyspnea - Reduction of nasal obstruction
Time frame: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)
1 secondary outcome
Will be assessed for safety by the incidence of adverse reactions
Time frame: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)
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 EMS Expectorant in people with Upper Airway Infections, 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 6 inclusion and 13 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. Some participants in this study may receive a placebo. 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 Karina Guerra, Coordinator (55 19 3829-3822, karina@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Decrease in nasal secretion - Decrease in sneezing - Reduction of edema of the nasal mucosa - Decreased frequency of cough - Decrease the frequency of dyspnea - Reduction of nasal obstruction (time frame: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)). 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.