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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026889
Receipt No. 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 2017/04/06

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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
Middle name
Last name Takeshi Hara
Organization Juntendo university
Division name Department of Neurosurgery
Zip code
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
Middle name
Last name Takeshi Hara
Organization Juntendo university
Division name Department of Neurosurgery
Zip code
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
Address
Tel
Email

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
2017 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.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


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