UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010982 |
|---|---|
| Receipt number | R000012858 |
| Scientific Title | A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis) |
| Date of disclosure of the study information | 2013/06/21 |
| Last modified on | 2016/02/05 16:20:44 |
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Basic information
Public title
A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Acronym
A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Scientific Title
A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Scientific Title:Acronym
A confirmatory study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Region
| Japan |
Condition
Condition
Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
SI-657 is injected once a week for 5 consecutive weeks, and the efficacy and safety will be evaluated in patients with enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis).
After the fifth injection, patients will be assigned to observational or continuous injection groups, and the safety and efficacy are also evaluated in each group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Change of Visual Analogue Scale (VAS) of pain at final evaluation.
Key secondary outcomes
Efficacy Outcomes
-Roles and Maudsley score
Safety Outcomes
-Adverse events
-Laboratory tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo
Interventions/Control_2
SI-657
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
2.Patients with 12 weeks or longer symptoms
3.Patients between 16 and 75 years old.
Key exclusion criteria
1.Patients who received localized injection at the involved limb or any steroid topical treatment within 2 weeks before administration.
2.Patients with acute symptoms (i.e., sprain, injury or surgery) at the affected site.
3.Patients with infectious risk at administration due to their skin disease or infection.
4.Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial.
Target sample size
540
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Muneta |
Organization
Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Division name
Division of Bio-Matrix, Graduate School.
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
SEIKAGAKU CORPORATION
Division name
Clinical Development Dept. Research & Development Div.
Zip code
Address
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-0005, Japan.
TEL
Homepage URL
Sponsor or person
Institute
KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
Institute
Department
Personal name
Funding Source
Organization
KAKEN PHARMACEUTICAL CO., LTD/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
| 2013 | Year | 06 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 17 | Day |
Last modified on
| 2016 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012858
| Research Plan | |
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| Registered date | File name |
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