UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017506 |
|---|---|
| Receipt number | R000020295 |
| Scientific Title | A clinical study on the potential therapeutic effects of intramuscular injection of G-CSF on the athlete patients with muscle strain injury |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2016/06/11 15:20:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study on the potential therapeutic effects of intramuscular injection of G-CSF on the athlete patients with muscle strain injury
Acronym
A clinical study on G-CSF and muscle injury
Scientific Title
A clinical study on the potential therapeutic effects of intramuscular injection of G-CSF on the athlete patients with muscle strain injury
Scientific Title:Acronym
A clinical study on G-CSF and muscle injury
Region
| Japan |
Condition
Condition
muscle strain injury
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the potential therapeutic effects of intramuscular injection of G-CSF on the athlete patients with muscle strain injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle regeneration and recovery of muscle strengthe
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intramuscular injection of G-CSF.
Standard treatment for muscle injury.
Interventions/Control_2
Standard treatment for muscle injury.
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
| 16 | years-old | < |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Within 3 days after injury.
Consent on the study.
Key exclusion criteria
Potentially pregnatn patients.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Nakamura |
Organization
Keio University School of Medicine
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
masa@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Harato |
Organization
Keio University School of Medicine
Division name
Dept. of Orthopedic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3812
Homepage URL
kharatoh@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University Kitasato Institute Hospital, Edogawa hospital
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
| 2015 | Year | 05 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 30 | 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
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020295
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
