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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010982
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012858

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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