Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 7:16 PM
Study NCT ID:
NCT00771160
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2008-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)
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': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2008-10-10', 'studyFirstSubmitQcDate': '2008-10-10', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any clinical or laboratory adverse experience', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'The daily mean of the composite nasal symptoms score at each of biweekly visits during the treatment period (average over the previous 2 weeks) or at time of termination', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic']}, 'descriptionModule': {'briefSummary': 'A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial Allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Patients With Perennial Allergic Rhinitis\n\nExclusion Criteria:\n\n* Patients Who Have Nasal Diseases (E.G., Nasal Polyp, Septonasal Arcuation, Hypertrophic Rhinitis), Upper Respiratory Infection, Sinusitis, Infectious Rhinitis And Those Disease Severe Enough To Interfere With Assessment Of Effectiveness\n* Patients Who Have Rhinitis Medicamentosa, Or Nonallergic Rhinitis (E.G., Vasomotor Rhinitis, Eosinophilia Rhinitis)\n* Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease'}, 'identificationModule': {'nctId': 'NCT00771160', 'briefTitle': 'MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'MK0476 Phase III Long-term Study -Perennial Allergic Rhinitis-', 'orgStudyIdInfo': {'id': '0476-397'}, 'secondaryIdInfos': [{'id': '2008_553'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MK0476 5mg', 'interventionNames': ['Drug: montelukast sodium']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'MK0476 10mg', 'interventionNames': ['Drug: montelukast sodium']}], 'interventions': [{'name': 'montelukast sodium', 'type': 'DRUG', 'otherNames': ['Singulair'], 'description': 'Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}