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

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Treatments: Ephedrine; Loratadine; Pseudoephedrine

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