UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004083 |
|---|---|
| Receipt number | R000004921 |
| Scientific Title | The influence of rifampicin discontinuation on rifampicin-induced cytochrome P450 enzyme activity |
| Date of disclosure of the study information | 2010/08/23 |
| Last modified on | 2012/01/05 13:19:34 |
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Basic information
Public title
The influence of rifampicin discontinuation on rifampicin-induced cytochrome P450 enzyme activity
Acronym
The influence of RFP discontinuation on CYP activity
Scientific Title
The influence of rifampicin discontinuation on rifampicin-induced cytochrome P450 enzyme activity
Scientific Title:Acronym
The influence of RFP discontinuation on CYP activity
Region
| Japan |
Condition
Condition
Mycobacterial infection
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the changes of CYP enzyme activity after rifampicin discontinuation.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assess pharmacokinetics of CYP substrate drugs with or without rifampicin.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
day-7>day-1: rifampicin 450mg
day-7, day0, day3, day7: midazoram 15ug/kg, omeprazole 20mg, dextromethorphan 30mg, losartan 50mg, caffein 100mg
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All participants must meet the following requirements.
:Age more than 20 years
:Systolic blood pressure at rest more than 100mmHg
:Written informed consent
Key exclusion criteria
Exclusion criterias are as follows.
:Drug hypersensitivity (particularly to agents included in the studies)
:Taking any medication
:History of alcohol or drug abuse
:History or presence of liver dysfunction
:History or presence of tuberculosis
:Participation in a clinical trial during the last 6 months prior to the start of the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
clinical pharmacology and therapeutics
Zip code
Address
1-20-1,Handayama,Higashi-ku,Hamamatsu-shi,Shizuoka,431-3192 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taisuke Akamatsu |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学(静岡県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 22 | Day |
Last modified on
| 2012 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004921
