Tibial shaft fracture
Conditions
Interventions
Arm P:A biodegradable gelatin hydrogel carrier
Arm L:A total dosage of 800 microgram of KCB-1 in a biodegradable gelatin hydrogel carrier
Arm H:A total dosage of 2400 microgram of KCB-1 in a biodegrad
Sponsors
Kaken Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Transverse or oblique tibial shaft fracture 2)Closed fracture or open fracture classified as Gustilo type1 treated with intramedullary nailing
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Bone union at 24 weeks after administration 2)Date of a bone union 3)Number and degree of adverse effects | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShinichi Kaiya
Kaken Pharmaceutical Co.,Ltd. Clinical Development Department
Outcome results
None listed