A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

This study has been terminated.
(Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).)
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00387686
First received: October 11, 2006
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Fractures
Drug: rhBMP-2/CPM
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture

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 objective of this study is to assess whether a single dose of rhBMP-2/CPM administered in combination with the SOC accelerates fracture union and return to normal function as indicated on radiographs and functional evaluations. [ Time Frame: efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 367
Study Start Date: November 2006
Study Completion Date: March 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
Experimental: B
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
Active Comparator: C
Buffer/CPM + surgical fixation Intervention
Drug: rhBMP-2/CPM
D
Standard of Care: Surgical fixation intervention
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, male and female subjects who are at least 18 years old.
  • Closed diaphyseal tibial fracture.
  • Closed reduction and definitive internal fixation by means of a reamed, locked intramedullary nail within 72 hours after injury.

Exclusion Criteria:

  • Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of weight bearing.
  • Planned procedure(s) to stimulate fracture healing after intramedullary nailing.
  • Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome.
  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: NCT00387686

  Show 69 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00387686     History of Changes
Other Study ID Numbers: 3100N7-210
Study First Received: October 11, 2006
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 18, 2014