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Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085721
First Posted: March 12, 2010
Last Update Posted: March 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
  Purpose

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 Intervention Phase
Viral Infections of the Upper Respiratory Tract Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin Drug: Dexchlorpheniramine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

Primary Outcome Measures:
  • Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS) [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor. [ Time Frame: 5 days ]

Estimated Enrollment: 170
Arms Assigned Interventions
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 Drug: Dexchlorpheniramine
5 mL (2 mg dexchlorpheniramine) qid for 5 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Pregnancy
  • HIV + patients
  • Other conditions considered by the investigator as reasonable for non-eligibility
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085721


Contacts
Contact: Claudia Domingues +551151885237 cdomingues@mantecorp.com

Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
  More Information

Responsible Party: Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltda.
ClinicalTrials.gov Identifier: NCT01085721     History of Changes
Other Study ID Numbers: POE/P/09-1
First Submitted: March 9, 2010
First Posted: March 12, 2010
Last Update Posted: March 12, 2010
Last Verified: March 2010

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
allergic rhinitis
viral infections of the upper respiratory tract
dexchlorpheniramine
pseudoephedrine
guaifenesin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Virus Diseases
Respiratory Tract Diseases
Pseudoephedrine
Phenylpropanolamine
Ephedrine
Chlorpheniramine, phenylpropanolamine drug combination
Guaifenesin
Dexchlorpheniramine
Chlorpheniramine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Expectorants
Adrenergic alpha-Agonists
Adrenergic Agonists
Appetite Depressants
Anti-Obesity Agents