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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038272
Receipt No. 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 2020/10/13

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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
Email 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
Email ce_pms@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 Not Applicable
Address Not Applicable
Tel Not Applicable
Email 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
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 Enrolling by invitation
Date of protocol fixation
2019 Year 04 Month 18 Day
Date of IRB
2019 Year 03 Month 08 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2019 Year 10 Month 11 Day
Last modified on
2020 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043626

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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