Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
NCT ID: NCT01085721
Last Updated: 2010-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
170 participants
INTERVENTIONAL
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexchlorpheniramine pseudoephedrine guaifenesin
Dexchlorpheniramine, pseudoephedrine, guaifenesin
5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
Dexchlorpheniramine
Dexchlorpheniramine
5 mL (2 mg dexchlorpheniramine) qid for 5 days
Interventions
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Dexchlorpheniramine, pseudoephedrine, guaifenesin
5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
Dexchlorpheniramine
5 mL (2 mg dexchlorpheniramine) qid for 5 days
Eligibility Criteria
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Inclusion Criteria
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent
* Patients who did not use forbidden medications
Exclusion Criteria
* 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)
* Pregnancy
* HIV + patients
* Other conditions considered by the investigator as reasonable for non-eligibility
18 Years
60 Years
ALL
No
Sponsors
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Mantecorp Industria Quimica e Farmaceutica Ltd.
INDUSTRY
Responsible Party
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Mantecorp Indústria Química e Farmacêutica Ltda.
Central Contacts
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Other Identifiers
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POE/P/09-1
Identifier Type: -
Identifier Source: org_study_id
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