UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011085
Receipt number R000012976
Scientific Title Influence of Multidrug resistance protein 4 (MRP4) on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide in Japanese healthy volunteers: open-label study
Date of disclosure of the study information 2013/07/01
Last modified on 2016/02/01 13:56:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Influence of Multidrug resistance protein 4 (MRP4) on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide in Japanese healthy volunteers: open-label study

Acronym

Influence of MRP4 on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide

Scientific Title

Influence of Multidrug resistance protein 4 (MRP4) on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide in Japanese healthy volunteers: open-label study

Scientific Title:Acronym

Influence of MRP4 on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide

Region

Japan


Condition

Condition

hyperuricemia

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To determine the effects of MRP4 genotype on serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide by clinical trials in Japanese healthy volunteers.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Relation between MRP4 genotype and the changes of serum uric acid levels and uric acid clearance after multiple administration of trichlormethiazide

Key secondary outcomes

Change of serum electrolytes, cholesterol, triglycerides, pulse rate and blood pressure
Ratio of side effects by trichlormethiazide


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

Administration of trichlormethiazide 4 mg/day for 14 days

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

Japanese healthy volunteers who are 20 years or older and younger than 50

Key exclusion criteria

1.Disease that should be treated
2. On medical treatment
3. Hepatic dysfunction(AST>40 IU/L or ALT>40 IU/L)
4. Renal dysfunction (serum creatinine level>1.2 mg/dL)
5. History of cardiovascular disease
6. Serum uric acid level >7.5 mg/dL
7. Abnormal electrolytes values (Na or K)
8. Hematocrit >55 %
9. Allergy reaction to thiazide and its related diuretics
10. Woman who is pregnant or breastfeeding
11. Systolic blood pressure <90 mmHg or >140 mmHg (sitting position)
12. Body weight <40 kg or >90 kg
13. Not appropriate to this study by other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sasaguri Toshiyuki

Organization

Faculty fo Medical Science, Kyushu University

Division name

Department of Clinical Pharmacology

Zip code


Address

3-1-1 Maidashi Higashi-ku Fukuoka, Japan

TEL

092-642-6082

Email

sasaguri@clipharm.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Yoshihara

Organization

Faculty of Medical Sciences, Kyushu University

Division name

Department of Clinical Pharmacology

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan

TEL

092-642-6082

Homepage URL


Email

tatsuya@clipharm.med.kyushu-u.ac.jp


Sponsor or person

Institute

Department of Clinical Pharmacology, Fuculty of Medicical Science, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 01 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

2013 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 07 Month 01 Day

Last modified on

2016 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012976


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name