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

Phase 3

Withdrawn

• Conditions: Allergic Rhinitis
• Interventions: Drug: Loratadine + Pseudoephedrine sulfate

• Registration Number: NCT01055756
• Lead Sponsor: Azidus Brasil

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.

Study Timeline

• Study First Submitted: 2009-12-10
• Study Start: 2010-01
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2010-04
• Study Completion: 2010-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test (Cloratadd D)	Loratadine + Pseudoephedrine sulfate	Loratadine + Pseudoephedrine sulfate Test
Comparator (Claritin D)	Loratadine + Pseudoephedrine sulfate	Loratadine + Pseudoephedrine Comparator

Primary Outcome Measures

Name	Time	Method
Clinical signs and symptoms and nasal flow	12 hours.

Secondary Outcome Measures

Name	Time	Method
Avaliation of Safety through the adverse affects observation	12 hours

Trial Locations

Locations (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda; 🇧🇷 Valinhos, São Paulo, Brazil