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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007239
Receipt No. R000008532
Scientific Title A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
Date of disclosure of the study information 2012/02/08
Last modified on 2014/09/18

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Basic information
Public title A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
Acronym A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
Scientific Title A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
Scientific Title:Acronym A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation
Region
Japan

Condition
Condition Lumbar Disc Herniation
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to verify the superiority of SI-6603 versus a placebo in subjects with lumbar disc herniation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline of pain due to lumbar disc herniation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SI-6603
Interventions/Control_2 Placebo
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed with lumbar disc herniation
2.Patients whose lumbar disc herniation failed to improve even after pharmacotherapy
Key exclusion criteria 1.Patients who have undergone lumbar operation in the past
2.Patients with diseases that can affect the results of this study
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Matsuyama, Kazuhiro Chiba
Organization Hamamatsu University School of Medicine, Kitasato Institute Hospital
Division name Department of Orthopedic Surgery, Department of Orthopedic Surgery
Zip code
Address 20-1 Handayama 1-chome Higashiku Hamamatsushi Shizuoka, 9-1 Shirokane 5-chome Minatoku Tokyo
TEL 053-435-2297
Email spine-yu@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiichi Shirogane
Organization SEIKAGAKU CORPORATION
Division name Research & Development Div. Clinical Development Dept.
Zip code
Address 6-1, Marunouchi 1-chome Chiyoda-ku Tokyo, Japan
TEL 03-5220-8593
Homepage URL
Email taiichi.shirogane@seikagaku.co.jp

Sponsor
Institute SEIKAGAKU CORPORATION
Institute
Department

Funding Source
Organization SEIKAGAKU CORPORATION
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 08 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 Completed
Date of protocol fixation
2011 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 07 Day
Last modified on
2014 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008532

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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