Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-02 @ 3:32 PM
Study NCT ID:
NCT01055756
Status:
WITHDRAWN
Last Update Posted:
2022-10-31
First Post:
2009-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017336', 'term': 'Loratadine'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical signs and symptoms and nasal flow', 'timeFrame': '12 hours.'}], 'secondaryOutcomes': [{'measure': 'Avaliation of Safety through the adverse affects observation', 'timeFrame': '12 hours'}]}, 'conditionsModule': {'keywords': ['Reduction of signs and symptoms and enhanced nasal flow', 'Nasal Flow'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Accept the Consent Form.\n2. Age between 18 and 60 years, regardless of sex;\n3. Agree to return to all evaluations of the study;\n4. 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.\n\nExclusion Criteria:\n\n1. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;\n2. 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;\n3. Be patient with sensitivity loratadine / pseudoephedrine sulfate;\n4. 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\n5. Demonstrate a history of alcohol abuse, drugs or pharmaceuticals.\n6. Have consumed alcohol within 48 hours prior to the period of hospitalization;\n7. Have a history of liver disease or kidney disease;\n8. Present framework of current asthma or recent (less than 1 year);\n9. To present the severe pressure of any cause or be on medication for that;\n10. Smokers or patients who stopped smoking less than 06 months;\n11. Pregnant or nursing women;\n12. Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;\n13. Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase;\n14. Patients with a history of glaucoma, urinary retention, and hyperthyroidism;\n15. Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow"}, 'identificationModule': {'nctId': 'NCT01055756', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'orgStudyIdInfo': {'id': 'LOREMS0909'}, 'secondaryIdInfos': [{'id': 'Version 3, Amendment 1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test (Cloratadd D)', 'description': 'Loratadine + Pseudoephedrine sulfate Test', 'interventionNames': ['Drug: Loratadine + Pseudoephedrine sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator (Claritin D)', 'description': 'Loratadine + Pseudoephedrine Comparator', 'interventionNames': ['Drug: Loratadine + Pseudoephedrine sulfate']}], 'interventions': [{'name': 'Loratadine + Pseudoephedrine sulfate', 'type': 'DRUG', 'description': 'Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)', 'armGroupLabels': ['Comparator (Claritin D)', 'Test (Cloratadd D)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13276245', 'city': 'Valinhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'LAL Clínica Pesquisa e Desenvolvimento Ltda', 'geoPoint': {'lat': -22.97056, 'lon': -46.99583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}