UMIN-CTR Clinical Trial

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

Enthesopathy (Lateral Epicondylitis, Patellar Tendinitis, Achilles Tendinitis and Plantar Fasciitis)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

SEIKAGAKU CORPORATION

Institute

Department

Personal name

Organization

SEIKAGAKU CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

KAKEN PHARMACEUTICAL CO., LTD.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

07

Month

20

Day

Last modified on

2011

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007118