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
This study has been withdrawn prior to enrollment.
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01055756
First received: December 10, 2009
Last updated: October 26, 2010
Last verified: February 2010
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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:
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
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 |
| 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
More Information
No publications provided
| 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 L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
|
Reduction of signs and symptoms and enhanced nasal flow Nasal Flow |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Pseudoephedrine Ephedrine Loratadine Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Central Nervous System Stimulants Central Nervous System Agents Sympathomimetics Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipruritics Dermatologic Agents Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013