UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007013
Receipt number R000008246
Scientific Title Effect of single dose administration of trichlormethiazide on the serum level and clearance of uric acid: open-label controlled dose-escalating trial with healthy Japanese male volunteers
Date of disclosure of the study information 2012/01/04
Last modified on 2012/03/13 13:10:13

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Basic information

Public title

Effect of single dose administration of trichlormethiazide on the serum level and clearance of uric acid: open-label controlled dose-escalating trial with healthy Japanese male volunteers

Acronym

Effect of single dose administration of trichlormethiazide on the serum level and clearance of uric acid

Scientific Title

Effect of single dose administration of trichlormethiazide on the serum level and clearance of uric acid: open-label controlled dose-escalating trial with healthy Japanese male volunteers

Scientific Title:Acronym

Effect of single dose administration of trichlormethiazide on the serum level and clearance of uric acid

Region

Japan


Condition

Condition

hyperuricemia

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To reveal whether single dose administration of trichlormethiazide (2, 4, 8 mg) changes the serum level and clearance of uric acid in comparison to no-treatment in healthy Japanese males.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in the serum uric acid level and uric acid clearance by single dose administration of trichlormethiazide

Key secondary outcomes

Relation between the polymorphisms of MRP4 and the serum uric acid level or uric acid clearance


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

no treatment

Interventions/Control_2

trichlormethiazide 2 mg

Interventions/Control_3

trichlormethiazide 4 mg

Interventions/Control_4

trichlormethiazide 8 mg

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

40 years-old >

Gender

Male

Key inclusion criteria

Healthy Japanese male volunteers (20-39 years old)

Key exclusion criteria

1. Disease that should be treated
2. On medical treatment
3. History of cardiovascular disease
4. Liver disease (AST >40 or ALT >40)
5. Kidney disease (serum creatinine >1.2 mg/dL)
6. Serum uric acid level >7.0 mg/dL
7. Serum electrolyte abnormality
8. Hematocrit >50%
9. Allergic reaction to thiazide and its related diuretics
10. Systolic blood pressure <90 mmHg or >140 mmHg
11. Body weight <40 kg or >90 kg
12. Not appropriate to this study by other reasons

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sasaguri Toshiyuki

Organization

Faculty of Medical Sciences, Kyushu University

Division name

Department of Clinical Pharmacology

Zip code


Address

3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan

TEL

+81-92-642-6082

Email



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


TEL

+81-92-642-6082

Homepage URL


Email

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


Sponsor or person

Institute

Department of Clinical Pharmacology, Faculty of Medical Sciences, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare(Japan)

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

九州大学先端医療イノベーションセンター


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 04 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

2011 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2012 Year 03 Month 01 Day

Date analysis concluded

2012 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 01 Month 04 Day

Last modified on

2012 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name