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Bone Morphogenetic Protein
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
Phase 2 & 3
Waitlist Available
Research Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.
Eligible Conditions
- Broken Bones
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: DExperimental Treatment1 Intervention
Standard of Care: Surgical fixation intervention
Group II: BExperimental Treatment1 Intervention
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Group III: AExperimental Treatment1 Intervention
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Group IV: CActive Control1 Intervention
Buffer/CPM + surgical fixation Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dibotermin alfa
FDA approved
Find a Location
Who is running the clinical trial?
Wyeth is now a wholly owned subsidiary of PfizerLead Sponsor
625 Previous Clinical Trials
248,072 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,555 Previous Clinical Trials
14,867,604 Total Patients Enrolled