Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-26 @ 1:53 AM
Study NCT ID:
NCT00723268
Status:
UNKNOWN
Last Update Posted:
2008-07-29
First Post:
2008-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005536', 'term': 'Foot-and-Mouth Disease'}, {'id': 'D019226', 'term': 'Oral Ulcer'}], 'ancestors': [{'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'lastUpdateSubmitDate': '2008-07-28', 'studyFirstSubmitDate': '2008-07-24', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of ulcers', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral ulcers'], 'conditions': ['Oral Aphthae']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.', 'detailedDescription': 'Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmation of clinical diagnosis of aphthae\n* Having the experience of oral aphthae at least once in a month\n* Two weeks wash out periods after the last treatment\n\nExclusion Criteria:\n\n* History of any systemic disease\n* Using drugs which affect immune system\n* Pregnancy and breast feeding\n* Aphthous related syndromes'}, 'identificationModule': {'nctId': 'NCT00723268', 'briefTitle': 'Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae', 'orgStudyIdInfo': {'id': '286293'}, 'secondaryIdInfos': [{'id': '286293'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone', 'interventionNames': ['Drug: Prednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colchicine', 'interventionNames': ['Drug: Colchicine']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'description': '5MG Prednisolone per day for 3 months', 'armGroupLabels': ['Prednisolone']}, {'name': 'Colchicine', 'type': 'DRUG', 'description': '0.5 MG Colchicine per day for 3 months', 'armGroupLabels': ['Colchicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91735', 'city': 'Mashhad', 'state': 'Khorasan Razavi', 'country': 'Iran', 'facility': 'Mashhad Dental school', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tehran', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Mashhad University of Medical Science', 'oldOrganization': 'Mashhad Dental Research Center'}}}}