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
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ClinicalTrials.gov Identifier: NCT01055756 |
Recruitment Status :
Withdrawn
First Posted : January 26, 2010
Last Update Posted : October 31, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Rhinitis | Drug: Loratadine + Pseudoephedrine sulfate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 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 |

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) |
- Clinical signs and symptoms and nasal flow [ Time Frame: 12 hours. ]
- Avaliation of Safety through the adverse affects observation [ Time Frame: 12 hours ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055756
Brazil | |
LAL Clínica Pesquisa e Desenvolvimento Ltda | |
Valinhos, São Paulo, Brazil, 13276245 |
Responsible Party: | Azidus Brasil |
ClinicalTrials.gov Identifier: | NCT01055756 |
Other Study ID Numbers: |
LOREMS0909 Version 3, Amendment 1 |
First Posted: | January 26, 2010 Key Record Dates |
Last Update Posted: | October 31, 2022 |
Last Verified: | October 2022 |
Reduction of signs and symptoms and enhanced nasal flow Nasal Flow |
Rhinitis Rhinitis, Allergic Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Loratadine Pseudoephedrine Ephedrine 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 |