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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000001344 |
Receipt No. | R000001632 |
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 |
Date of disclosure of the study information | 2009/01/01 |
Last modified on | 2016/02/18 |
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
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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
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Scientific Title:Acronym | Neurotropin Trial | |
Region |
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Condition | ||
Condition | Lumbar spinal canal stenosis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Keio University, School of Medicine | ||||||
Division name | Dept. of Orthopaedic Surgery, | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjyuku, Tokyo, Japan | ||||||
TEL | 03-3353-1211 | ||||||
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |