UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study on the potential therapeutic effects of intramuscular injection of G-CSF on the athlete patients with muscle strain injury
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masaya Nakamura
Organization	Keio University School of Medicine
Division name	Dept. of Orthopaedic Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	masa@keio.jp

Public contact
Name of contact person	Kengo Harato
Organization	Keio University School of Medicine
Division name	Dept. of Orthopedic Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3812
Homepage URL
Email	kharatoh@yahoo.co.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 08 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020295