UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047422 |
|---|---|
| Receipt number | R000054080 |
| Scientific Title | Perioperative duloxetine administration reduces pain after high tibial osteotomy and non-steroidal anti-inflammatory administration |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2022/04/06 17:54:51 |
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Basic information
Public title
Perioperative duloxetine administration reduces pain after high tibial osteotomy and non-steroidal anti-inflammatory administration
Acronym
The effect of perioperative duloxetine administration for pain reduction
Scientific Title
Perioperative duloxetine administration reduces pain after high tibial osteotomy and non-steroidal anti-inflammatory administration
Scientific Title:Acronym
The effect of perioperative duloxetine administration for pain reduction
Region
| Japan |
Condition
Condition
osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether perioperative duloxetine administration reduces pain after knee surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Numeric rating scale
Key secondary outcomes
Pain catastrophizing Scale
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients in the duloxetine group received one 20-mg capsule once daily for 1 week at 3 weeks before surgery and two 20-mg capsules once daily for 2 weeks before surgery.
Interventions/Control_2
Patients received non-steroidal anti-inflammatory drugs (NSAIDs; 60 mg) for severe pain, and three tablets per day were permitted as the maximum dose.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis
Key exclusion criteria
Rheumatoid arthritis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Otsuki |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of orthopedic surgery
Zip code
569-8686
Address
2-7 Daigakumachi Takatsuki Osaka Japan
TEL
0726831221
Shuhei.otsuki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Otsuki |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of orthopedic surgery
Zip code
569-8686
Address
2-7 Daigakumachi Takatsuki Osaka Japan
TEL
0726831221
Homepage URL
Shuhei.otsuki@ompu.ac.jp
Sponsor or person
Institute
Department of orthopedic surgery, Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
no
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
Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi Takatsuki Osaka Japan
Tel
0726831221
Shuhei.otsuki@ompu.ac.jp
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
| 2022 | Year | 04 | Month | 06 | 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
80
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
| 2019 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054080
