Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 8:05 PM
Study NCT ID:
NCT01224834
Status:
COMPLETED
Last Update Posted:
2010-11-08
First Post:
2010-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of Ragweed SLIT Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-05', 'studyFirstSubmitDate': '2010-10-13', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Immunological markers (IgE and IgG4)', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ragweed, allergy, sublingual immunotherapy'], 'conditions': ['Rhinitis, Allergic, Seasonal', 'Ragweed Pollen Allergy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written consent\n* male or female subjects from 18 yo 60 years old and in general good health\n* for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method\n* symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years\n* sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) \\> 0.70 kU/l at screening\n* FEV1 at least of 80% of predicted value at screening\n\nExclusion Criteria:\n\n* past or current disease which, as judged by the investigator, may affect the outcome of this study\n* history of life-threatening asthma\n* asthma requiring daily treatment (whatever the pharmaceutical class)\n* pregnant or lactating women\n* subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study\n* symptoms during the treatment phase due to a sensitivity to a second allergen\n* subjects treated with ongoing immunotherapy with another allergen'}, 'identificationModule': {'nctId': 'NCT01224834', 'briefTitle': 'Safety and Tolerability Study of Ragweed SLIT Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stallergenes Greer'}, 'officialTitle': 'Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.', 'orgStudyIdInfo': {'id': 'VO63.08 HUN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Sublingual tablet of ragweed pollen allergen extract']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Sublingual tablet of ragweed pollen allergen extract']}], 'interventions': [{'name': 'Sublingual tablet of ragweed pollen allergen extract', 'type': 'DRUG', 'description': 'administered once a day over 10 days', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H-8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'DRC Drug Research Center', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}], 'overallOfficials': [{'name': 'Eva Péterfai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRC Drug Research Center, Balatonfüred - Hungary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stallergenes Greer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Olivier de Beaumont/Medical Director', 'oldOrganization': 'Stallergenes SA'}}}}