Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
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|ClinicalTrials.gov Identifier: NCT01085721|
Recruitment Status : Unknown
Verified March 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was: Not yet recruiting
First Posted : March 12, 2010
Last Update Posted : March 12, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Viral Infections of the Upper Respiratory Tract||Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin Drug: Dexchlorpheniramine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Experimental: Dexchlorpheniramine pseudoephedrine guaifenesin||
Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin
5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
|Active Comparator: Dexchlorpheniramine||
5 mL (2 mg dexchlorpheniramine) qid for 5 days
- Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS) [ Time Frame: 5 days ]
- Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor. [ Time Frame: 5 days ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085721
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