UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008218 |
|---|---|
| Receipt number | R000009685 |
| Scientific Title | PhaseII Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis) |
| Date of disclosure of the study information | 2012/06/21 |
| Last modified on | 2012/11/29 10:50:55 |
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Basic information
Public title
PhaseII Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis)
Acronym
PhaseII Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis)
Scientific Title
PhaseII Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis)
Scientific Title:Acronym
PhaseII Study of SI-657 in Patients with Enthesopathy (Lateral Epicondylitis)
Region
| Japan |
Condition
Condition
Enthesopathy (Lateral Epicondylitis)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study objectives are to evaluate the efficacy and safety of SI-657 exploratively in patients with enthesopathy (lateral epicondylitis).
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
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo group
Interventions/Control_2
SI-657 group
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 lateral epicondylitis
2.Patients with 12 weeks or longer symptoms
3.Patients between 20 and 75 years old.
Key exclusion criteria
1.Patients who received local injection or steroid topical treatment at the arm affected with lateral epicondylitis within 2 weeks before the first administration.
2.Patients with pain due to complication other than lateral epicondylitis around the affected site.
3.Patients with infectious risk at the administration site due to skin disease or infection.
Target sample size
40
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
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, Japan/6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo, Japan
TEL
03-5977-5111.03-5220-8593
Homepage URL
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
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 | 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
| 2012 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 06 | Month | 20 | 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=R000009685
