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Trial record 1 of 1 for:    NCT00384852
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A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

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ClinicalTrials.gov Identifier: NCT00384852
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : February 28, 2013
Sponsor:
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
 (submitted: June 29, 2009)
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
 (submitted: October 3, 2006)
The primary efficacy variable in this study is radiographic union.
Change History Complete list of historical versions of study NCT00384852 on ClinicalTrials.gov Archive Site
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
  • Experimental: A
    1.0 mg/mL rhBMP-2/CPM + SOC
    Intervention: Drug: rhBMP-2/CPM
  • Experimental: B
    2.0 mg/mL rhBMP-2/CPM + SOC
    Intervention: Drug: rhBMP-2/CPM
  • Active Comparator: C
    Buffer/CPM + SOC
    Intervention: Drug: rhBMP-2/CPM
  • D
    Standard of Care Alone (SOC)
    Intervention: Drug: rhBMP-2/CPM
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
 (submitted: April 12, 2010)
139
Original Enrollment  ICMJE
 (submitted: October 3, 2006)
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:

  • Skeletally mature subjects age 18 years or older.
  • Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
  • Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.

Exclusion Criteria:

  • Shoulder dislocation at the time of injury.
  • Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
  • Fractures located in the distal third of humerus.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Brazil, xavierl@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezzlj@wyeth.com
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