CoughPhase 3NCT01257243
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment
A Phase 3 study testing Syrup of oxomemazine, guaifenesin and potassium iodate and Syrup of guaifenesin in people with Cough, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cough
- What is being tested?
- Syrup of oxomemazine, guaifenesin and potassium iodate and Syrup of guaifenesin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2012to 25 Oct 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
- Cough score superior to 3.
Who cannot join
- Pregnancy or risk of pregnancy.
- Lactation.
- Fever above 38º C.
- Patients with bacterial infections of the upper respiratory tract.
- Any pathology or past medical condition that can interfere with this protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro
São Paulo, 02189-000
About this study
Official title: Multicentric, Randomized, Open-label Trial to Evaluate the Superiority of Fixed Dose Combination of Oxomemazine, Guaifenesin and Potassium Iodate to Guaifenesin Monotherapy in Acute Cough Treatment
The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.
Read the detailed description
STUDY DESIGN
- Open-label, superiority, prospective, parallel group, intent to treat trial
- Experiment duration: 7 days
- 3 visits (days 1, 2 and 7)
- Reduction cough symptoms
- Adverse events evaluation
- Conditions
- Cough
- Being tested
- Syrup of oxomemazine, guaifenesin and potassium iodate, Syrup of guaifenesin
- Keywords
- cough, symptoms, cold, flu
- Medical subject headings
- Cough, Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syrup of oxomemazine, guaifenesin and potassium iodateDrug
5ml each 4 hours
Syrup of guaifenesinDrug
5ml each 4 hours
| Study group | Role | What they receive |
|---|---|---|
| DRUG 1 | Experimental | Syrup of oxomemazine, guaifenesin and potassium iodate Receives: Drug: Syrup of oxomemazine, guaifenesin and potassium iodate |
| DRUG 2 | Active comparator | Syrup of guaifenesin Receives: Drug: Syrup of guaifenesin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction/improvement of cough symptoms
The reduction of cough symptoms will be evaluated by comparative score index basal and final score
Measured: DAY 7
Secondary outcomes (1)
Tolerance
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: DAY 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study start1 Oct 2012
- Primary completion30 Sep 2013
- Study completion25 Oct 2013
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.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felipe Pinho, MD, Study director, EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257243
- Sponsor's protocol ID
- OGPGEMS0110
- Status last verified
- Apr 2019
- First submitted
- 8 Dec 2010
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized, Open-label Trial to Evaluate the Superiority of Fixed Dose Combination of Oxomemazine, Guaifenesin and Potassium Iodate to Guaifenesin Monotherapy in Acute Cough Treatment
- ClinicalTrials.gov ID
- NCT01257243
- Acronym / sponsor ID
- OGPGEMS0110
- Conditions
- Cough
- Keywords
- cough, symptoms, cold, flu
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 25 Oct 2013 (actual)
- First posted
- 9 Dec 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.
The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.
Detailed description
STUDY DESIGN
- Open-label, superiority, prospective, parallel group, intent to treat trial
- Experiment duration: 7 days
- 3 visits (days 1, 2 and 7)
- Reduction cough symptoms
- Adverse events evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DRUG 1 | Experimental | Drug: Syrup of oxomemazine, guaifenesin and potassium iodateSyrup of oxomemazine, guaifenesin and potassium iodate |
| DRUG 2 | Active comparator | Drug: Syrup of guaifenesinSyrup of guaifenesin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
- Cough score superior to 3.
Key exclusion criteria (5 listed)
- Pregnancy or risk of pregnancy.
- Lactation.
- Fever above 38º C.
- Patients with bacterial infections of the upper respiratory tract.
- Any pathology or past medical condition that can interfere with this protocol.
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 |
|---|---|---|
| Syrup of oxomemazine, guaifenesin and potassium iodate5ml each 4 hours | Drug | DRUG 1 |
| Syrup of guaifenesin5ml each 4 hours | Drug | DRUG 2 |
Primary outcome
Reduction/improvement of cough symptoms
Time frame: DAY 7
The reduction of cough symptoms will be evaluated by comparative score index basal and final score
1 secondary outcome
Tolerance
Time frame: DAY 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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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.
Felipe Pinho, MD study director
EMS
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 Syrup of oxomemazine, guaifenesin and potassium iodate and Syrup of guaifenesin in people with Cough, run by EMS 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction/improvement of cough symptoms (time frame: DAY 7). 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 17 Apr 2019.