UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008414 |
|---|---|
| Receipt number | R000009888 |
| Scientific Title | Controlled study to investigate management methods of gout attack for gout patients with uric-acid lowering therapy |
| Date of disclosure of the study information | 2012/07/12 |
| Last modified on | 2015/05/26 18:32:15 |
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Basic information
Public title
Controlled study to investigate management methods of gout attack for gout patients with uric-acid lowering therapy
Acronym
FORTUNE-1
Scientific Title
Controlled study to investigate management methods of gout attack for gout patients with uric-acid lowering therapy
Scientific Title:Acronym
FORTUNE-1
Region
| Japan |
Condition
Condition
Gout with Hyperuricemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing management methods of gout attack at the starting period of uric-acid lowering therapy with febuxostat.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence rate (percentage of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the treatment period" (the first twelve weeks of the study).
Key secondary outcomes
- Frequency of occurrence (number of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the treatment period" (the first twelve weeks of the study);
- Frequency of occurrence (Number of the patients who needed analgesic treatment with NSAIDs or adrenal corticosteroid) of gout attack (predictors are not included) during "the observation period" (entire period of the study);
- Achievement rate of serum uric-acid level of 6.0 mg/dL or lower during "the observation period" (entire period of the study).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration:
24 weeks
Dosage:
Start from 10mg/day febuxostat. Increased to 20 mg/day at the week 5 and to 40mg/day at the week 9. Maintain 40mg/day to the week 24
Administration:
PO, s.i.d.
Interventions/Control_2
Duration:
24 weeks (colchicine for 12 weeks)
Dosage:
40mg/day febuxostat and 0.5mg/day colchicine
Administration:
PO, s.i.d. (each)
Interventions/Control_3
Duration:
24 weeks
Dosage:
40mg/day febuxostat
Administration:
PO, s.i.d.
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
Key inclusion criteria
Patients who fulfill all five criteria below are eligible for the study:
1) Gout patients with uric acid level over 7.0 mg/dL who are not under treatment with any uric-acid lowering drugs;
2) Patients who had gout attack in the last twelve months;
3) Patients are aged 20 years or older at the time of acquisition of informed consent;
4) Patients who are not hospitalized (out-patient status);
5) Patient who consents in writing to participate in the study.
Key exclusion criteria
Patients who meet any of the sixteen criteria below are ineligible for the study:
1) Patients who have previous history of hypersensitivity to febuxostat;
2) Patients who have previous history of hypersensitivity to colchicine;
3) Patients who have previous history of hypersensitivity to NSAIDs or patients who have not been affected by NSAIDs;
4) Patients who had gout attack in the last two weeks;
5) Patients who have used any uric-acid lowering drugs in the last four weeks;
6) Patients with secondary hyperuricemia;
7) Patients who have twice as high AST or ALT as the hospital's reference value;
8) Patients with serum creatinine level of 2.0 mg/dL or higher;
9) Patients who have or have had past history of malignant tumor as a complication requiring treatment;
10) Patients who are being treated with either mercaptopurine hydrate or azathioprine;
11) Patients with peptic ulcer;
12) Patients with serious hematological disorder;
13) Patients with serious cardiac disorder;
14) Patients with aspirin-induced asthma or its previous history;
15) Patients who participated in another clinical study or clinical trial in the six months prior to the confirmation of eligibility;
16) Patients who the doctor in charge judges are ineligible for the study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Yamanaka |
Organization
Tokyo Women's Medical University
Division name
Institute of Rheumatology
Zip code
Address
10-22, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-5269-1711
yamanaka@ior.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Oi |
Organization
Mebix, Inc.
Division name
Clinical Research III
Zip code
Address
1-11-44 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-6229-8936
Homepage URL
http://cms.captool.jp/fortune-1/
fortune@mebix.co.jp
Sponsor or person
Institute
Clinical research consortium on uric acid
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 12 | 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
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 12 | Day |
Last modified on
| 2015 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009888
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| Registered date | File name |
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| Registered date | File name |
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