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

Primary Purpose

Chronic Kidney Disease, Tuberculosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rifampicin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Kidney Disease

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Rifampicin

    Arm Description

    experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin

    Outcomes

    Primary Outcome Measures

    a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration

    Secondary Outcome Measures

    Full Information

    First Posted
    December 7, 2011
    Last Updated
    August 26, 2013
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01932268
    Brief Title
    A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, Tuberculosis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rifampicin
    Arm Type
    Experimental
    Arm Description
    experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin
    Intervention Type
    Drug
    Intervention Name(s)
    Rifampicin
    Other Intervention Name(s)
    Rifampin
    Intervention Description
    single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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

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