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

Last updated: October 27, 2022
Sponsor: Azidus Brasil
Overall Status: Trial Not Available

Phase

3

Condition

Common Cold

Allergies & Asthma

Allergy

Treatment

N/A

Clinical Study ID

NCT01055756
LOREMS0909
Version 3, Amendment 1
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 laboratorytests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which shouldprovide a diagnosis of allergic rhinitis with mild to moderate.

Exclusion

Exclusion Criteria:

  1. Have participated in any experimental study or have ingested any drug trial in the 12months preceding the start of the study;
  2. Made use of other medications that interfere with the regular response of the drug inthe 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 theanalysis 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 thatis suffering interference of the drugs studied, for example, β-blockers;
  13. Patients using corticosteroids or other medicines that interact with the study drugsas 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 Start date:
January 01, 2010
Estimated Completion Date:
June 30, 2010

Study 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.

Connect with a study center

  • LAL Clínica Pesquisa e Desenvolvimento Ltda

    Valinhos, São Paulo 13276245
    Brazil

    Site Not Available

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