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Status: Withdrawn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 ClÃnica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo 13276245, Brazil
Additional Information
Starting date: January 2010
Last updated: October 26, 2010
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