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

NCT ID: NCT01055756

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-06-30

Brief 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.

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test (Cloratadd D)

Loratadine + Pseudoephedrine sulfate Test

Group Type: EXPERIMENTAL

Loratadine + Pseudoephedrine sulfate

Intervention Type: DRUG

Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)

Comparator (Claritin D)

Loratadine + Pseudoephedrine Comparator

Group Type: ACTIVE_COMPARATOR

Loratadine + Pseudoephedrine sulfate

Intervention Type: DRUG

Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)

Interventions

Loratadine + Pseudoephedrine sulfate

Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Version 3, Amendment 1

Identifier Type: -

Identifier Source: secondary_id

LOREMS0909

Identifier Type: -

Identifier Source: org_study_id