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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006014
Receipt No. R000007118
Scientific Title Multicenter and Open-label Phase IIa Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Date of disclosure of the study information 2011/07/22
Last modified on 2011/11/30

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Basic information
Public title Multicenter and Open-label Phase IIa Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Acronym Multicenter and Open-label Phase IIa Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Scientific Title Multicenter and Open-label Phase IIa Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)
Scientific Title:Acronym Multicenter and Open-label Phase IIa 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 The study objectives are to assess the safety and the maximum injectable volume of SI-657 in patients with enthesopathy. In addition, efficacy is evaluated exploratively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1.Safety Outcomes
- Adverse Events
- Laboratory tests
2.Maximum injectable volume at each site
Key secondary outcomes Efficacy Outcomes
- Visual Analogue Scale of pain
- Roles and Maudsley score

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SI-657
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
20 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 4 weeks or longer symptoms

3.Patients between 20 and 75 years old.
Key exclusion criteria 1.Patients who received localized injection at the involved site or any steroid topical treatment within 2 weeks before administration.

2.Exclusion criteria for each disease are below.
- Lateral Epicondylitis:
Patients with more severe pain due to complications within the affected upper limb than lateral epicondylitis.
- Patellar Tendinitis:
Patients with more severe pain due to complications within the affected lower leg than patellar tendinitis.
- Achilles Tendinitis, Plantar Fasciitis:
Patients with acute symptoms (i.e., sprain, injury or surgery) at the affected foot.

3.Patients with rheumatic joint diseases.

4.Patients with infectious risk at administration due to their skin disease or infection.

5.Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial.
Target sample size 60

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 Section of Orthopaedic Surgery, 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 Hiroyuki Hosokawa
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 03-5220-8593
Homepage URL
Email

Sponsor
Institute SEIKAGAKU CORPORATION
Institute
Department

Funding Source
Organization SEIKAGAKU CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor KAKEN PHARMACEUTICAL CO., LTD.
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
2011 Year 07 Month 22 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
2011 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 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
2011 Year 07 Month 20 Day
Last modified on
2011 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007118

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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