UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000847 |
|---|---|
| Receipt number | 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 17:26:13 |
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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
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
kaiya_shinichi@kaken.co.jp
Sponsor or person
Institute
Kaken Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000974
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