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A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin

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ClinicalTrials.gov Identifier: NCT01932268
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Tuberculosis Drug: Rifampicin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rifampicin
experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin
Drug: Rifampicin
single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration
Other Name: Rifampin




Primary Outcome Measures :
  1. a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration [ Time Frame: the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • from 18yrs to 80yrs , man and women
  • the patient who are taking rifampicine over 2weeks
  • the patient sign on the concent form

Exclusion Criteria:

  • the patient have experience to take medication that have an effect on renal function
  • the patient have hypersensitivity to colchicine
  • 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
  • uncontrolled hypertension
  • serum albumin < 3.5, > 5 g/dL
  • 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
  • the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
  • the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
  • the patient who had taken part in the other study within 3months
  • the patient who had gotten blood transfusion
  • pregnant, breast feeding
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01932268    
Other Study ID Numbers: Colchicine_RFP 2011_1
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Tuberculosis
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers