UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034723 |
|---|---|
| Receipt number | R000039578 |
| Scientific Title | General Drug Use Survey of HERNICORE 1.25 units for intradiscal injection in Patients with Lumbar Disc Herniation |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/10/13 13:16:07 |
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Basic information
Public title
General Drug Use Survey of HERNICORE 1.25 units for intradiscal injection in Patients with Lumbar Disc Herniation
Acronym
HERNICORE General Drug Use Survey
Scientific Title
General Drug Use Survey of HERNICORE 1.25 units for intradiscal injection in Patients with Lumbar Disc Herniation
Scientific Title:Acronym
HERNICORE General Drug Use Survey
Region
| Japan |
Condition
Condition
Lumbar Disc Herniation
Classification by specialty
| Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect safety (detection of unknown adverse drug reactions and understanding of the occurrence of other adverse drug reactions) and efficacy under actual conditions of use as well as factors affecting them
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
- Occurrence of adverse events and adverse reactions
- Occurrence of post-treatment surgery for lumbar spinal instability at the same level of administration of HERNICORE
Efficacy
- Improvement of leg pain and low back pain
- Occurrence of post-treatment surgery for lumbar disc herniation at the same level of administration of HERNICORE - Global assessment (physician)
Key secondary outcomes
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
HERNICORE naive patients with subligamentous extruded lumbar disc herniation with no sufficient improvement after a conservative therapy
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tadamasa |
| Middle name | |
| Last name | Kobayashi |
Organization
SEIKAGAKU CORPORATION
Division name
Pharmacovigilance Dept.
Zip code
100-0005
Address
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
TEL
03-5220-8556
HER_GPSP_2_SKK@seikagaku.co.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Endo |
Organization
SEIKAGAKU CORPORATION
Division name
Pharmacovigilance Dept.
Zip code
100-0005
Address
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
TEL
03-5220-8556
Homepage URL
HER_GPSP_2_SKK@seikagaku.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
SEIKAGAKU CORPORATION
Address
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
Tel
03-5220-8556
HER_GPSP_2_SKK@seikagaku.co.jp
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
| 2018 | Year | 11 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
Other
Other related information
Planned registration period: November 2018 - December 2021
Registration method: Central registration method
Observation period: 3 months after administration
Ethics Committee approval not applicable for investigation.
Management information
Registered date
| 2018 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039578
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
