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Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00384358 |
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.
Condition | Intervention | Phase |
---|---|---|
Fractures |
Drug: rhBMP-2/CPM |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur |
Enrollment: | 108 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | February 2011 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
1.0 mg/mL rhBMP-2/CPM + surgical fixation
|
Drug: rhBMP-2/CPM |
B: Experimental
2.0 mg/mL rhBMP-2/CPM + surgical fixation
|
Drug: rhBMP-2/CPM |
C
Control: Surgical fixation
|
Drug: rhBMP-2/CPM |
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3100N7-211 |
Study First Received: | October 3, 2006 |
Last Updated: | June 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00384358 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Fractures |
Fractures, Bone Adjuvants, Immunologic Wounds and Injuries Disorders of Environmental Origin |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |