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 - Full Text View

Purpose

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	Intervention	Phase
Allergic Rhinitis	Drug: Loratadine + Pseudoephedrine sulfate	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Ephedrine Hydrochloride Pseudoephedrine Ephedrine sulfate Pseudoephedrine hydrochloride Sulfate ion Loratadine

U.S. FDA Resources

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:

Clinical signs and symptoms and nasal flow [ Time Frame: 12 hours. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Avaliation of Safety through the adverse affects observation [ Time Frame: 12 hours ] [ Designated as safety issue: No ]


Estimated Enrollment:	32
Study Start Date:	January 2010
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Accept the Consent Form.
Age between 18 and 60 years, regardless of sex;
Agree to return to all evaluations of the study;
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:

Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
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;
Be patient with sensitivity loratadine / pseudoephedrine sulfate;
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
Demonstrate a history of alcohol abuse, drugs or pharmaceuticals.
Have consumed alcohol within 48 hours prior to the period of hospitalization;
Have a history of liver disease or kidney disease;
Present framework of current asthma or recent (less than 1 year);
To present the severe pressure of any cause or be on medication for that;
Smokers or patients who stopped smoking less than 06 months;
Pregnant or nursing women;
Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase;
Patients with a history of glaucoma, urinary retention, and hyperthyroidism;
Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055756

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 History of Changes
Other Study ID Numbers:	LOREMS0909 Version 3, Amendment 1
Study First Received:	December 10, 2009
Last Updated:	October 26, 2010
Health Authority:	Brazil: National Health Surveillance Agency

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 Ephedrine Pseudoephedrine Antipruritics Dermatologic Agents	Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Nasal Decongestants Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 23, 2016