UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008540 |
|---|---|
| Receipt number | R000010040 |
| Scientific Title | Effects of pregabalin on post operative neurogenic inflammation after total knee arthroplasty. |
| Date of disclosure of the study information | 2012/07/26 |
| Last modified on | 2018/09/11 15:05:18 |
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Basic information
Public title
Effects of pregabalin on post operative neurogenic inflammation after total knee arthroplasty.
Acronym
Effects of pregabalin on post operative neurogenic inflammation after total knee arthroplasty.
Scientific Title
Effects of pregabalin on post operative neurogenic inflammation after total knee arthroplasty.
Scientific Title:Acronym
Effects of pregabalin on post operative neurogenic inflammation after total knee arthroplasty.
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We were planning a clinical study to prove the leg swelling caused total knee arthroplasty in neurogenic inflammation due to injury of the inferior branch patellar saphenous nerve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of the circumstance of thigh and lowerleg after 4 weeks from start of administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pregabalin
Interventions/Control_2
serecoxib
Interventions/Control_3
NSAIDs suppository
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Knee OA accept for TKA
Key exclusion criteria
rheumatoid arthritis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Inoue |
Organization
aichi medical university
Division name
orthopedic surgery
Zip code
Address
21 Yazako-Karimata, Nagakute, Aichi, 480-1195, JAPAN
TEL
0561-62-3311
sinoue0626@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Inoue |
Organization
aichi medical university
Division name
orthopedic surgery
Zip code
Address
aichi nagakuteshi yazako karimata 1-1
TEL
0561-62-3311
Homepage URL
sinoue0626@gmail.com
Sponsor or person
Institute
aichi medical university
Institute
Department
Personal name
Funding Source
Organization
aichi medical university
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
愛知医科大学
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2012 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010040
