UMIN-CTR Clinical Trial

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
Email	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
Email	thara79nouge@gmail.com

Sponsor
Institute	Juntendo university Department of Neurosurgery
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	Juntendo university hospoital ethics commitee
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo Japan
Tel	03-3813-3111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030847