UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038272 |
|---|---|
| Receipt number | R000043626 |
| Scientific Title | A Multicenter, Post-Market Observational (non-interventional) Study of SUPARTZ in Subjects with Osteoarthritis of the Knee or Periarthritis of the Shoulder |
| Date of disclosure of the study information | 2019/10/21 |
| Last modified on | 2023/04/18 14:50:25 |
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Basic information
Public title
A Multicenter, Post-Market Observational (non-interventional) Study of SUPARTZ in Subjects with Osteoarthritis of the Knee or Periarthritis of the Shoulder
Acronym
Post-Market Observational Study of SUPARTZ
Scientific Title
A Multicenter, Post-Market Observational (non-interventional) Study of SUPARTZ in Subjects with Osteoarthritis of the Knee or Periarthritis of the Shoulder
Scientific Title:Acronym
Post-Market Observational Study of SUPARTZ
Region
| Europe |
Condition
Condition
Osteoarthritis of the Knee or Periarthritis of the Shoulder
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to assess the safety of SUPARTZ in subjects with osteoarthritis of the knee or periarthritis of the shoulder in the clinical daily practice in Italy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
- Occurrence of adverse events and adverse reactions
Key secondary outcomes
Efficacy
- Changes from baseline of pain in osteoarthritis (OA) of the knee and periarthritis of the shoulder
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who provide their written informed consent.
2. Subject who has a diagnosis of OA of the knee or periarthritis of the shoulder at the time of before first injection. The definition of OA of the knee is reference to the following American College of Rheumatology (ACR) criteria.
Key exclusion criteria
1. Subjects for whom the product is contraindicated according to the Instructions For Use or subjects to whom, in any case, the product is administered not in accordance with the Instructions For Use.
2. Subjects with a history of hypersensitivity due to any ingredients of SUPARTZ.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Shimojima |
Organization
SEIKAGAKU CORPORATION
Division name
Quality assurance
Zip code
100-0005
Address
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
TEL
03-5220-8556
ce_pms@seikagaku.co.jp
Public contact
Name of contact person
| 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
Homepage URL
ce_pms@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
Not Applicable
Address
Not Applicable
Tel
Not Applicable
Not Applicable
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
| 2019 | Year | 10 | Month | 21 | 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
60
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
| 2019 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 10 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 16 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043626
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
