Viral Infections of the Upper Respiratory TractPhase 3NCT01085721
Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
A Phase 3 study testing Dexchlorpheniramine, pseudoephedrine, guaifenesin and Dexchlorpheniramine in people with Viral Infections of the Upper Respiratory Tract, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
Trial summary
Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Viral Infections of the Upper Respiratory Tract
- What is being tested?
- Dexchlorpheniramine, pseudoephedrine, guaifenesin and Dexchlorpheniramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with allergic rhinitis with symptoms of viral infection of the upper respiratory tract (rhinorrhea, nasal obstruction and productive cough)
- Compliance of the subject to the treatment protocol
- Agreement with the terms of the informed consent
- Patients who did not use forbidden medications
Who cannot join
- History of allergy to any component of the formulations
- Use of any investigational drug within the last 30 days
- Patients with bacterial infections of the upper respiratory tract
- Patients with high blood pressure (> 140 x 90 mmHg)
- Patients who are receiving inhaled beta-agonists or other antihistamine, decongestant or expectorant
- Patients with known pulmonary disease (asthma, COPD, neoplasias)
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- Pregnancy
- HIV + patients
- Other conditions considered by the investigator as reasonable for non-eligibility
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in the Relief of Allergic Symptoms in Rhinitic Patients With Viral Upper Respiratory Tract Infections and Productive Cough
Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production.
The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.
- Being tested
- Dexchlorpheniramine, pseudoephedrine, guaifenesin, Dexchlorpheniramine
- Keywords
- allergic rhinitis, viral infections of the upper respiratory tract, dexchlorpheniramine, pseudoephedrine, guaifenesin
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexchlorpheniramine, pseudoephedrine, guaifenesinDrug
5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
DexchlorpheniramineDrug
5 mL (2 mg dexchlorpheniramine) qid for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Dexchlorpheniramine pseudoephedrine guaifenesin | Experimental | Not described Receives: Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin |
| Dexchlorpheniramine | Active comparator | Not described Receives: Drug: Dexchlorpheniramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
Measured: 5 days
Secondary outcomes (1)
Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Infections of the Upper Respiratory TractStudies 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085721
- Sponsor's protocol ID
- POE/P/09-1
- Status last verified
- Mar 2010
- First submitted
- 9 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in the Relief of Allergic Symptoms in Rhinitic Patients With Viral Upper Respiratory Tract Infections and Productive Cough
- ClinicalTrials.gov ID
- NCT01085721
- Acronym / sponsor ID
- POE/P/09-1
- Keywords
- allergic rhinitis, viral infections of the upper respiratory tract, dexchlorpheniramine, pseudoephedrine, guaifenesin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.Industry (pharma, biotech, devices)
- First posted
- 12 Mar 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.
Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production.
The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexchlorpheniramine pseudoephedrine guaifenesin | Experimental | Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin |
| Dexchlorpheniramine | Active comparator | Drug: Dexchlorpheniramine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with allergic rhinitis with symptoms of viral infection of the upper respiratory tract (rhinorrhea, nasal obstruction and productive cough)
- Compliance of the subject to the treatment protocol
- Agreement with the terms of the informed consent
- Patients who did not use forbidden medications
Key exclusion criteria (9 listed)
- History of allergy to any component of the formulations
- Use of any investigational drug within the last 30 days
- Patients with bacterial infections of the upper respiratory tract
- Patients with high blood pressure (> 140 x 90 mmHg)
- Patients who are receiving inhaled beta-agonists or other antihistamine, decongestant or expectorant
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 |
|---|---|---|
| Dexchlorpheniramine, pseudoephedrine, guaifenesin5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days | Drug | Dexchlorpheniramine pseudoephedrine guaifenesin |
| Dexchlorpheniramine5 mL (2 mg dexchlorpheniramine) qid for 5 days | Drug | Dexchlorpheniramine |
Primary outcome
Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
Time frame: 5 days
1 secondary outcome
Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexchlorpheniramine, pseudoephedrine, guaifenesin and Dexchlorpheniramine in people with Viral Infections of the Upper Respiratory Tract, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
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 4 inclusion and 9 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 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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 Claudia Domingues (+551151885237, cdomingues@mantecorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS) (time frame: 5 days). 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 12 Mar 2010.