UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015221 |
|---|---|
| Receipt number | R000017357 |
| Scientific Title | Follow-up study of LDH patients participated in the Phase II/III study (6603/1021) and Phase III study (6603/1031) of condoliase (SI-6603) |
| Date of disclosure of the study information | 2014/09/22 |
| Last modified on | 2015/03/10 11:53:05 |
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Basic information
Public title
Follow-up study of LDH patients participated in the Phase II/III study (6603/1021) and Phase III study (6603/1031) of condoliase (SI-6603)
Acronym
Follow-up study of LDH patients participated in the SI-6603 clinical study
Scientific Title
Follow-up study of LDH patients participated in the Phase II/III study (6603/1021) and Phase III study (6603/1031) of condoliase (SI-6603)
Scientific Title:Acronym
Follow-up study of LDH patients participated in the SI-6603 clinical study
Region
| Japan |
Condition
Condition
Lumbar Disc Herniation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long term safety and efficacy in patients who were administered SI-6603 in the past clinical study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of post-treatment lumbar surgery
Key secondary outcomes
Occurrence of lumbar instability
Clinical symptoms and daily disability resulting from lumbar diseases
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who were administered SI-6603 in the clinical study
Key exclusion criteria
Patients who have not given their written informed consent to participate in the follow-up study.
Target sample size
356
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Funakoshi |
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
yosuke.funakoshi@seikagaku.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Ono |
Organization
Mebix, Inc.
Division name
Clinical Research Division
Zip code
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-6229-8936
Homepage URL
si-6603@mebix.co.jp
Sponsor or person
Institute
SEIKAGAKU CORPORATION
Institute
Department
Personal name
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
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
| 2014 | Year | 09 | Month | 22 | 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
| 2014 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Occurrence of post-treatment lumbar surgery
Management information
Registered date
| 2014 | Year | 09 | Month | 22 | Day |
Last modified on
| 2015 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017357
