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A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00384852
First received: October 3, 2006
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Fractures
Drug: rhBMP-2/CPM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: January 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
1.0 mg/mL rhBMP-2/CPM + SOC
Drug: rhBMP-2/CPM
Experimental: B
2.0 mg/mL rhBMP-2/CPM + SOC
Drug: rhBMP-2/CPM
Active Comparator: C
Buffer/CPM + SOC
Drug: rhBMP-2/CPM
D
Standard of Care Alone (SOC)
Drug: rhBMP-2/CPM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384852

  Show 38 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00384852     History of Changes
Other Study ID Numbers: 3100N7-212
Study First Received: October 3, 2006
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Fracture
Humerus

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014