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
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
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
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
