Trial record 1 of 1 for:
NCT00384852
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00384852 |
|
Recruitment Status :
Completed
First Posted : October 6, 2006
Last Update Posted : February 28, 2013
|
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | October 3, 2006 | |||||||||
| First Posted Date ICMJE | October 6, 2006 | |||||||||
| Last Update Posted Date | February 28, 2013 | |||||||||
| Study Start Date ICMJE | January 2007 | |||||||||
| Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
The primary efficacy variable in this study is radiographic union. [ Time Frame: Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone. ] | |||||||||
| Original Primary Outcome Measures ICMJE |
The primary efficacy variable in this study is radiographic union. | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | A Study of rhBMP-2/CPM in Closed Fractures of the Humerus | |||||||||
| Official Title ICMJE | A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus | |||||||||
| Brief Summary | The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 2 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
|||||||||
| Condition ICMJE | Fractures | |||||||||
| Intervention ICMJE | Drug: rhBMP-2/CPM | |||||||||
| Study Arms ICMJE |
|
|||||||||
| Publications * | Not Provided | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
139 | |||||||||
| Original Enrollment ICMJE |
132 | |||||||||
| Actual Study Completion Date ICMJE | February 2010 | |||||||||
| Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender ICMJE |
|
|||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Australia, Brazil, Canada, Finland, France, Germany, Mexico, Norway, Romania, Sweden, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00384852 | |||||||||
| Other Study ID Numbers ICMJE | 3100N7-212 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
|
|||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Verification Date | February 2013 | |||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||||||||