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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034723
Receipt No. 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 2018/12/10

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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
Last name of lead principal investigator
1st name
Middle name
Last name Tadamasa Kobayashi
Organization SEIKAGAKU CORPORATION
Division name Pharmacovigilance Dept.
Zip code
Address 6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
TEL 03-5220-8556
Email HER_GPSP_2_SKK@seikagaku.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kazuki Endo
Organization SEIKAGAKU CORPORATION
Division name Pharmacovigilance Dept.
Zip code
Address 6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
TEL 03-5220-8556
Homepage URL
Email HER_GPSP_2_SKK@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
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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Planned registration period: November 2018 - December 2021
Registration method: Central registration method
Observation period: 3 months after administration

Management information
Registered date
2018 Year 10 Month 31 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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