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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030409
Receipt No. 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 2019/07/22

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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
Email 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
Email wsaito@kiasato-u.ac.jp

Sponsor
Institute Department of Orhopaedic Suegery, Kitasato University School of Medicine
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034715

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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