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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007257
Receipt No. R000008563
Scientific Title A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)
Date of disclosure of the study information 2012/02/10
Last modified on 2012/11/29

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Basic information
Public title A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)
Acronym A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)
Scientific Title A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)
Scientific Title:Acronym A Dose-finding Phase II Study of SI-657 in Patients with Enthesopathy (Plantar Fasciitis)
Region
Japan

Condition
Condition Enthesopathy (Plantar Fasciitis)
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study objectives are to evaluate the efficacy and safety, and to determine the recommended dose of SI-657 in patients with enthesopathy (plantar fasciitis).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Efficacy Outcome
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
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Placebo group
Interventions/Control_2 SI-657 high-dose group
Interventions/Control_3 SI-657 low-dose group
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 -Patients diagnosed with plantar fasciitis
-Patients with 12 weeks or longer symptoms
-Patients between 20 and 75 years old
Key exclusion criteria -Patients who received local injection or steroid topical treatment at the leg affected with plantar faciitis within 2 weeks before the first administration.
-Patients with acute symptoms (i.e., sprain, injury or surgery) at the affected foot.
-Patients with infectious risk at the administration site due to their skin disease or infection.
Target sample size 180

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, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Yorozuya/Hiroyuki Hosokawa
Organization KAKEN PHARMACEUTICAL CO., LTD/SEIKAGAKU CORPORATION
Division name Clinical Development Department/Clinical Development Dept. Research & Development Div.
Zip code
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo/6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo
TEL 03-5977-5111(03-5220-8593)
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 Japan

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
2012 Year 02 Month 10 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 12 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 21 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
2012 Year 02 Month 09 Day
Last modified on
2012 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008563

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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