UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030409 |
|---|---|
| Receipt number | R000034715 |
| Scientific Title | The study of the effect of Duloxisetine on postoperative residual pain, numbness and abnormal sensitivity after spinal surgery |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2021/01/18 07:27:31 |
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Basic information
Public title
The study of the effect of Duloxisetine on postoperative residual pain, numbness and abnormal sensitivity after spinal surgery
Acronym
Effect of Duloxisetine on residual pain after spinal surgery
Scientific Title
The study of the effect of Duloxisetine on postoperative residual pain, numbness and abnormal sensitivity after spinal surgery
Scientific Title:Acronym
Effect of Duloxisetine on residual pain after spinal surgery
Region
| Japan |
Condition
Condition
Cervical spondylotic myelopathy
Lumbar disc herniation
Lumbar cannal stenosis
Cervical disc herniation
Thoracic disc herniation
Ossification of posterior longitudinal ligament
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy on the residual pain, numbness and abnormal sensituvity after spinal surgery and safety of Duloxicetine, Pregabaline and An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of pain, numbness and abnormal sensitivity with Visual Analog Scale
Key secondary outcomes
JOA CMEQ
JOA BPEQ
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
Patients will receive for 3 months from the day after surgery. In Duloxisetin group, they will start medication from 20mg/day and increase up to 60mg/day weekly.
Interventions/Control_2
Patients will receive for 3 months from the day after surgery. In Pregabaline group, they will start medication from 50mg/day and increase up to 150mg/day weekly.
Interventions/Control_3
Patients will receive for 3 months from the day after surgery. In An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus gruop, they will start medication from 4U/day and keep this dose for 3 monts.
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who performed spinal surgery
Key exclusion criteria
Patients who have
allergy to drugs
mental depression
severe liver disease
severe kidney disease
gastrointestinal ulcer
heart failure
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Saito |
Organization
Kitasato University School of Medicine
Division name
Department of Orhopaedic Surgery
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
wsaito@kiasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Saito |
Organization
Kitasato University School of Medicine
Division name
Department of Orhopaedic Surgery
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
wsaito@kiasato-u.ac.jp
Sponsor or person
Institute
Department of Orhopaedic Suegery, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Kitasato institute, Clinical research Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8273
rinrib@med.kitasato-u.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
| 2017 | Year | 12 | Month | 18 | 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
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034715
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
