UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007257
Receipt number 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 10:50:30

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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 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

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

Value
https://center6.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