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Comparative Effectiveness of Two Associations of Loratadine + Pseudoephedrine, Cloratadd-d ® (Coated Pill) Produced by the Laboratory Ems and Claritin-d ® (dräger), Produced by Schering-plough in Patients With Perennial Allergic Rhinitis

Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Perennial Allergic Rhinitis

Intervention: Loratadine + pseudoephedrine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Summary

The hypothesis to be investigated in this study is that drug testing is as effective as the comparator drug, with regard to relief of symptoms of perennial allergic rhinitis.

Clinical Details

Official title: Evaluating the Effectiveness of Two Commercial Preparations of Loratadine + Pseudoephedrine Cloratadd-d (Coated Pill) Produced by the Laboratory EMS S / AE Claritin-d (drger), Produced by Schering-plough SA, in Patients With Perennial Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Signs and symptoms evaluated by a PHYSICIAN

Secondary outcome: Symptoms reported by PATIENTS

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Comply with all the purposes and procedures of the study by signing and dating the IC

own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;

- Have age over 12 years, regardless of gender, ethnicity or social class;

- Present clinical status of perennial allergic rhinitis from mild to moderate;

- Present clinical status with at least 12 months of evolution;

- Submit the examination of IgE elevation (above 100KU / L).

Exclusion Criteria:

- Have participated in any experimental study or have taken any experimental drug in

the 12 months preceding the start of the study;

- Pregnant or lactating women;

- Have made use of:

1. Intranasal or systemic corticosteroids in the month before inclusion; 2. Intranasal cromolyn in the two weeks preceding inclusion; 3. Intranasal or systemic decongestants in the 03 days preceding inclusion; 4. Intranasal antihistamines or systemic in the 03 days preceding the survey; 5. Loratadine in the 10 days preceding the survey.

- have any disease or anatomical abnormality in the upper airways which could

jeopardize the analysis of data, for example, tumors or severe septal deviations;

- History of smoking in the 03 months preceding the inclusion;

- History of alcohol or illicit drugs;

- History of liver disease or kidney disease;

- Electric current asthma or gift last year;

- Table of uncontrolled hypertension;

- Patients with heart disease or who use drugs for the cardiovascular system that is

suffering interference of the drugs studied, for example, β-blockers;

- Patients with flu-like symptoms or fever of unknown origin, defined current or within

last 07 days;

- Clinical diagnosis of rhinitis is not that kind of allergic and perennial;

- Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components

of the formula;

- Estimated travel or displacement of the southeast for more than 50% of monitoring.

Locations and Contacts

Lal Clínica Pesquisa E Desenvolvimento Ltda, Valinhos, Sao Paulo 13270-245, Brazil
Additional Information

Starting date: August 2011
Last updated: February 22, 2013

Page last updated: August 20, 2015

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