UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026889 |
|---|---|
| Receipt number | R000030847 |
| Scientific Title | The study of usefulness and safety of pregabalin for numbness of spinal disease |
| Date of disclosure of the study information | 2017/04/09 |
| Last modified on | 2021/04/10 11:58:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study of usefulness and safety of pregabalin for numbness of spinal disease
Acronym
The effect of pregabalin for the numbness of the spine disease
Scientific Title
The study of usefulness and safety of pregabalin for numbness of spinal disease
Scientific Title:Acronym
The effect of pregabalin for the numbness of the spine disease
Region
| Japan |
Condition
Condition
Spine and Spinal cord disease
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pregabalin is a drug for treating neuropathic pain, but few reports have examined numbness which is one symptom of neuropathic pain.
We study the effectiveness and safety of pregabalin against numbness of spinal diseases often associated with nociceptive pain and neuropathic pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The degree of numbness(VAS)
Key secondary outcomes
The degree of pain(VAS)
The score of sleep disturbance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Test drug name: product name (common name) Lyrica (pregabalin)
Manufacturer selling agency / Sales alliance: Pfizer Inc. / Eisai Co., Ltd.
As an initial dose, pregabalin 150 mg / day is administered orally twice a day, then over 1 week the daily dose to 300 mg gradually.
Continue administration for 12 weeks and evaluate outcomes at the start, 4, 8 and 12 weeks.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients complaining numbness of due to spine and spinal cord diseases.
2.Patients undergoing conservative therapy
3.Subjects who gained document consent by free will with sufficient understanding after the principal received sufficient explanation for participation in this study.
Key exclusion criteria
1.Patients with a history of hypersensitivity to pregabalin.
2.Patients who were the subject of surgical treatment.
3.Patients who are judged inappropriate as the subject by reserch director.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hara |
Organization
Juntendo university
Division name
Department of Neurosurgery
Zip code
113-0033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
thara79nouge@gmail.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hara |
Organization
Juntendo university
Division name
Department of Neurosurgery
Zip code
113-0033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111
Homepage URL
thara79nouge@gmail.com
Sponsor or person
Institute
Juntendo university
Department of Neurosurgery
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
Juntendo university hospoital ethics commitee
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 09 | 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
| 2017 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030847
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
