Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01448902
Status:
COMPLETED
Last Update Posted:
2011-10-07
First Post:
2011-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced 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': 'C571151', 'term': '(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-06', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score', 'timeFrame': '8 days', 'description': 'To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours as shown by the effect on Total Nasal Symptom Score'}], 'secondaryOutcomes': [{'measure': 'OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs', 'timeFrame': '8 days', 'description': 'To assess the safety of this treatment schedule in male subjects with allergic rhinitis as assessed via adverse events, clinical chemistry and haematology, FEV1 and vital signs.'}, {'measure': 'OC000459 plasma concentration (Cmin)', 'timeFrame': '8 days', 'description': 'To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergic rhinitis', 'CRTH2'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '23025511', 'type': 'DERIVED', 'citation': 'Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Collins LP, Hunter MG, Steiner J, Lewis T, Payton MA, Perkins CM, Pettipher R. The CRTH2 antagonist OC000459 reduces nasal and ocular symptoms in allergic subjects exposed to grass pollen, a randomised, placebo-controlled, double-blind trial. Allergy. 2012 Dec;67(12):1572-9. doi: 10.1111/all.12042. Epub 2012 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.\n* Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.\n* FEV1 within normal limits (≥90% of predicted).\n* Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.\n* Asymptomatic at screening\n* Non smokers for at least the past 12 months\n\nExclusion Criteria:\n\n* Medical conditions likely to affect the outcome of the study.\n* Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.\n* Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function\n* Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.'}, 'identificationModule': {'nctId': 'NCT01448902', 'briefTitle': 'A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oxagen Ltd'}, 'officialTitle': 'A Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'OC000459/007/06'}, 'secondaryIdInfos': [{'id': '2007-000017-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OC000459', 'interventionNames': ['Drug: OC000459']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'OC000459', 'type': 'DRUG', 'description': 'OC000459 200mg bid for 8 days', 'armGroupLabels': ['OC000459']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo bid for 8 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Vienna Challenge Chamber', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Friedrich Horak, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vienna Challenge Chamber'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxagen Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}