A proof-of-concept study of SB-751689 in male and female with a fractured distal radius. - SB-751689 in patients with a fractured wrist

GlaxoSmithKline0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•1. Informed Consent: Subject is willing and able to provide written informed consent
•2. Fracture type: Extra-articular distal radius fractures AO/ASIF types 23-A2 and 23-A3 are permissible.
•3. Fracture treatment: Received conservative treatment of the distal radius fracture, including closed reduction and immobilization device
•4. Men or Women: Ambulatory males or females aged *35 to < 80 years of age who have sustained a closed, unilateral, fracture of the distal radius no more than 5 days prior to randomization.
•5. Protocol compliance

•1. Timing of fracture: Any treatment of a fractured distal radius that occurred more than 5 days after the fracture sustaining injury
•2. Fracture: All B- and C-type fractures (intra-articular) according to AO Fracture classification that would likely require open reduction and internal fixation
•3. Prior fractures: Prior fracture of the same wrist as an adult
•6. Bone metabolism: History or concurrent diseases affecting bone metabolism (e.g., osteomalacia, hyperparathyroidism, hyperthyroidism, etc.)
•7. Skeleton: History of skeletal immaturity or pathologic (tumor-related) fracture
•8. Arthritis
•9 Thyroid hormone replacement, Subjects will be excluded if TSH levels are <0.1 or >10.0 mIU/L. If TSH is >4.5 to <10.0 mIU/mL, measure T4 and exclude the subject only if the T4 is outside the normal range
•12. Malignancy: Malignant disease diagnosed within the previous 5 years or active peptic ulcer disease
•14. Liver disease
•15. Drug or alcohol abuse: Drug or alcohol abuse (past or current) within the previous 12 months
•18. Surgical and medical conditions

发起方