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

Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01055756
• Other study ID #: LOREMS0909
• Secondary ID: Version 3, Amend
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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, ß-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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Loratadine + Pseudoephedrine sulfate
Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)

Locations

Country	Name	City	State
Brazil	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical signs and symptoms and nasal flow		12 hours.
Secondary	Avaliation of Safety through the adverse affects observation		12 hours