Clinical Trial: Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase 2 Randomised, Open-label, Multi-centre Ascending Dose Study of the Efficacy, Safety and Tolerability of I-040302 Versus Control Injection (Bone Marrow Aspirate or Steroids) in Children and You
Brief 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.
Detailed Summary:
Sponsor: Kuros Biosurgery AG
Current Primary Outcome: Radiographic images [ Time Frame: At 6 months and throughout the study ]
Original Primary Outcome: Radiographic images
Current Secondary Outcome:
- Blood parameters [ Time Frame: At 6 months and throughout the study ]
- Vital signs [ Time Frame: At 6 months and throughout the study ]
- Questionnaires of life questionnaire [ Time Frame: At 6 months and throughout the study ]
- Pharmacoeconomic evaluation [ Time Frame: At 6 months and throughout the study ]
Original Secondary Outcome:
- Clinical assessments of the fracture site
- Blood parameters
- Vital signs
- Questionnaires of life
- Pharmacoeconomic evaluation
Information By: Kuros Biosurgery AG
Dates:
Date Received: April 11, 2007
Date Started: December 2012
Date Completion: July 2019
Last Updated: July 16, 2012
Last Verified: July 2012