Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-30 @ 1:31 PM
Study NCT ID:
NCT01932268
Status:
COMPLETED
Last Update Posted:
2013-08-30
First Post:
2011-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-26', 'studyFirstSubmitDate': '2011-12-07', 'studyFirstSubmitQcDate': '2013-08-26', 'lastUpdatePostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration', 'timeFrame': 'the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease', 'Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* from 18yrs to 80yrs , man and women\n* the patient who are taking rifampicine over 2weeks\n* the patient sign on the concent form\n\nExclusion Criteria:\n\n* the patient have experience to take medication that have an effect on renal function\n* the patient have hypersensitivity to colchicine\n* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \\<= 100 mmHg or \\>=160 mmHg and DBP \\<=60 mmHg \\>=100 mmHg, or Heart rate \\< 40 beats/min or \\> 90 beats/min\n* uncontrolled hypertension\n* serum albumin \\< 3.5, \\> 5 g/dL\n* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL\n* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.\n* the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid\n* the patient who had taken part in the other study within 3months\n* the patient who had gotten blood transfusion\n* pregnant, breast feeding"}, 'identificationModule': {'nctId': 'NCT01932268', 'briefTitle': 'A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'Colchicine_RFP 2011_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifampicin', 'description': 'experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin', 'interventionNames': ['Drug: Rifampicin']}], 'interventions': [{'name': 'Rifampicin', 'type': 'DRUG', 'otherNames': ['Rifampin'], 'description': 'single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration', 'armGroupLabels': ['Rifampicin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}