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

• ClinicalTrials.gov Identifier: NCT01055756
• Recruitment Status: Withdrawn
• First Posted: January 26, 2010
• Last Update Posted: October 28, 2010
• Sponsor: Azidus Brasil
• Information provided by: Azidus Brasil

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Allergic Rhinitis	Drug: Loratadine + Pseudoephedrine sulfate	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: January 2010
• Estimated Primary Completion Date: April 2010
• Estimated Study Completion Date: June 2010

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Clinical signs and symptoms and nasal flow [ Time Frame: 12 hours. ]

Secondary Outcome Measures :

1. Avaliation of Safety through the adverse affects observation [ Time Frame: 12 hours ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Brazil

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil, 13276245

Sponsors and Collaborators

Azidus Brasil

More Information

• Responsible Party: Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda.
• ClinicalTrials.gov Identifier: NCT01055756
• Other Study ID Numbers: LOREMS0909; Version 3, Amendment 1
• First Posted: January 26, 2010
• Last Update Posted: October 28, 2010
• Last Verified: February 2010

Keywords provided by Azidus Brasil:

Reduction of signs and symptoms and enhanced nasal flow; Nasal Flow

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Loratadine; Pseudoephedrine; Ephedrine; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Nasal Decongestants; Vasoconstrictor Agents; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antipruritics; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating