UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015668 |
|---|---|
| Receipt number | R000018168 |
| Scientific Title | The efficacy of tranilast after carpal tunnel release; randomized controlled trial |
| Date of disclosure of the study information | 2014/11/12 |
| Last modified on | 2014/11/11 23:25:46 |
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Basic information
Public title
The efficacy of tranilast after carpal tunnel release; randomized
controlled trial
Acronym
The efficacy of tranilast after carpal tunnel release; randomized controlled trial
Scientific Title
The efficacy of tranilast after carpal tunnel release; randomized
controlled trial
Scientific Title:Acronym
The efficacy of tranilast after carpal tunnel release; randomized controlled trial
Region
| Japan |
Condition
Condition
carpal tunnel syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to reveal the efficacy of tranilast after carpal tunnel release.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JSSH version of CTS instrument
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
carpal tunnel release
Interventions/Control_2
medicines for internal use
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 patients that are diagnosed with carpal tunnel syndrome and need a surgery.
Key exclusion criteria
previous surgery in the affected hand, trauma to the affected hand, inflammatory joint disease, mental disease, pregnancy, hypersensitivity to the tranilast
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Hirata |
Organization
Nagoya University Graduate School of Medicine
Division name
Hand surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-744-2957
hiroya.kawamoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya Kawamoto |
Organization
Nagoya University Graduate School of Medicine
Division name
Hand surgery
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-744-2957
Homepage URL
hiroya.kawamoto@med.nagoya-u.ac.jp
Sponsor or person
Institute
Hand Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2014 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | 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
| 2014 | Year | 11 | Month | 11 | Day |
Last modified on
| 2014 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018168
