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

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.

Study Overview

• Status: Withdrawn
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Loratadine + Pseudoephedrine sulfate

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil, 13276245
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test (Cloratadd D); Loratadine + Pseudoephedrine sulfate Test	Drug: Loratadine + Pseudoephedrine sulfate; Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)
Active Comparator: Comparator (Claritin D); Loratadine + Pseudoephedrine Comparator	Drug: Loratadine + Pseudoephedrine sulfate; Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical signs and symptoms and nasal flow	12 hours.

Secondary Outcome Measures

Outcome Measure	Time Frame
Avaliation of Safety through the adverse affects observation	12 hours

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: December 10, 2009
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Reduction of signs and symptoms and enhanced nasal flow; Nasal Flow
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Central Nervous System Stimulants; Sympathomimetics; Histamine H1 Antagonists, Non-Sedating; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine; Loratadine
• Other Study ID Numbers: LOREMS0909; Version 3, Amendment 1