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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000847
Receipt No. R000000974
Scientific Title Therapeutic exploratory study of KCB-1B for patients with tibial shaft fracture
Date of disclosure of the study information 2007/10/11
Last modified on 2009/06/02

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Basic information
Public title Therapeutic exploratory study of KCB-1B for patients with tibial shaft fracture
Acronym Therapeutic exploratory study of KCB-1B
Scientific Title Therapeutic exploratory study of KCB-1B for patients with tibial shaft fracture
Scientific Title:Acronym Therapeutic exploratory study of KCB-1B
Region
Japan

Condition
Condition Tibial shaft fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of KCB-1B single administration for patients of tibial shaft fracture,randomized,placebo-controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 1)Bone union at 24 weeks after administration
2)Date of a bone union
3)Number and degree of adverse effects
Key secondary outcomes 1)Secondary intervention
2)Date of start full-weight bearing
3)Tenderness or pain and period to disappearance of those
4)Aftereffect
5)Serum KCB-1 level
6)Serum anti-KCB-1B antibody

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm P:A biodegradable gelatin hydrogel carrier
Interventions/Control_2 Arm L:A total dosage of 800 microgram of KCB-1 in a biodegradable gelatin hydrogel carrier
Interventions/Control_3 Arm H:A total dosage of 2400 microgram of KCB-1 in a biodegradable gelatin hydrogel carrier
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)Transverse or oblique tibial shaft fracture
2)Closed fracture or open fracture classified as Gustilo type1 treated with intramedullary nailing
Key exclusion criteria 1)Multi fragmentary fracture
2)Pathological fracture
3)Patients with other sites fracture affecting loading exercise
4)Osteoporosis
5)History or complication of malignancy
6)History of allergy to food or medicine which contain gelatine
7)History of allergy to protein preparation
8)History of anaphylactic shock or status asthmaticus
9)Received administration of other trial drugs within 24 weeks
10)Pregnant women, nursing mothers or possibly pregnant women
11)Complication of serious renal disorders,liver disorders,hematological disorders and circulatory system disorders
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Tamura
Organization Kaken Pharmaceutical Co.,Ltd.
Division name Clinical Development Department
Zip code
Address 28-8,Honkomagome 2-chome,Bunkyo-ku,Tokyo
TEL 03-5977-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kaiya
Organization Kaken Pharmaceutical Co.,Ltd.
Division name Clinical Development Department
Zip code
Address 28-8,Honkomagome 2-chome,Bunkyo-ku,Tokyo
TEL 03-5977-5111
Homepage URL
Email kaiya_shinichi@kaken.co.jp

Sponsor
Institute Kaken Pharmaceutical Co.,Ltd.
Institute
Department

Funding Source
Organization Kaken Pharmaceutical Co.,Ltd.
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
2007 Year 10 Month 11 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
2005 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 10 Month 10 Day
Last modified on
2009 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000974

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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