drugset / Trial / NCT00459641
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.
Timeline
- Start
- 2012-12
- Primary completion
- 2014-06
- Completion
- 2019-07
Outcome
Outcome not reported
Stopped (Enrollment): “Stopped before any site initiation or any recruitment due to change in overall product development plan”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | I-040302 | Unknown | 1 mg | Other |
| Subject | I-040302 | Unknown | 2 mg | Other |
| Subject | I-040302 | Unknown | 4 mg | Other |