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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004083
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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