UMIN-CTR Clinical Trial

Basic information
Public title	Prospective randomized clinical trial for evaluation of efficacy of Neurotropin in patients with lumbar spinal canal stenosis presenting with residual leg symptoms after decompression surgery
Acronym	Neurotropin Trial
Scientific Title	Prospective randomized clinical trial for evaluation of efficacy of Neurotropin in patients with lumbar spinal canal stenosis presenting with residual leg symptoms after decompression surgery
Scientific Title:Acronym	Neurotropin Trial
Region	Japan

Condition
Condition	Lumbar spinal canal stenosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the efficacy of Neurotropin for residual symptoms after surgery in patietns with lumbar spinal canal stenosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	visual analogue scales for pain and numbness in the lower extremities
Key secondary outcomes	Japanese Orthopaedic Association Score for Low Back Pain

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Neurotropin
Interventions/Control_2	Methycobal
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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with lumbar spinal canalstenosis presenting with residual symptoms in the lower extremities
Key exclusion criteria	Patients with diabetic neuropathy, ASO, allergy to Neurotropin Patients who take pshychoactive drugs
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Morio Matsumoto
Organization	Keio University, School of Medicine
Division name	Dept. of Orthopaedic Surgery,
Zip code
Address	35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL	03-3353-1211
Email

Public contact
Name of contact person	1st name Middle name Last name Morio Matsumoto
Organization	Keio University, School of Medicine
Division name	Dept. of Orthopaedic Surgery,
Zip code
Address	35 Shinanomachi, Shinjyuku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	morio@sc.itc.keio.ac.jp

Sponsor
Institute	Dept. of Orthopedic surgery, Keio University, School of Medicine
Institute
Department

Funding Source
Organization	Nippon Zoki
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	NA
Name of secondary funder(s)	NA

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

Other administrative information
Date of disclosure of the study information	2009 Year 01 Month 01 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	Terminated
Date of protocol fixation	2008 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2009 Year 12 Month 01 Day
Date of closure to data entry	2010 Year 02 Month 01 Day
Date trial data considered complete	2010 Year 03 Month 01 Day
Date analysis concluded	2010 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2008 Year 08 Month 30 Day
Last modified on	2016 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001632

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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