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Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With 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: Allergic Rhinitis

Intervention: Loratadine + Pseudoephedrine sulfate (Drug)

Phase: Phase 3

Status: Withdrawn

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

Summary

The primary objective of this study is to evaluate the clinical efficacy of the drug

Cloratadd D (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin

D (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic

rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical signs and symptoms and nasal flow

Secondary outcome: Avaliation of Safety through the adverse affects observation

Detailed description: Secondly, it will be observed safety (tolerability) clinic after the administration of the drug in patients by comparing the clinical parameters and the incidence of adverse events.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Accept the Consent Form. 2. Age between 18 and 60 years, regardless of sex; 3. Agree to return to all evaluations of the study; 4. Presenting the allergic symptoms confirmed by physical examination and by laboratory tests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which should provide a diagnosis of allergic rhinitis with mild to moderate. Exclusion Criteria: 1. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study; 2. Made use of other medications that interfere with the regular response of the drug in the 4 weeks preceding the start of the study, such as steroids and antihistamines; 3. Be patient with sensitivity loratadine / pseudoephedrine sulfate; 4. Have any disease or anatomical abnormality in the upper airways is detrimental to the analysis of data, for example, tumors or septal deviations moderate and severe 5. Demonstrate a history of alcohol abuse, drugs or pharmaceuticals. 6. Have consumed alcohol within 48 hours prior to the period of hospitalization; 7. Have a history of liver disease or kidney disease; 8. Present framework of current asthma or recent (less than 1 year); 9. To present the severe pressure of any cause or be on medication for that; 10. Smokers or patients who stopped smoking less than 06 months; 11. Pregnant or nursing women; 12. Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers; 13. Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase; 14. Patients with a history of glaucoma, urinary retention, and hyperthyroidism; 15. Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow

Locations and Contacts

LAL Clínica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo 13276245, Brazil
Additional Information

Starting date: January 2010
Last updated: October 26, 2010

Page last updated: August 20, 2015

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