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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387686

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-3708
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
Pfizer Investigational Site
Denver, Colorado, United States, 80204
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
United States, Florida
Pfizer Investigational Site
Pinellas Park, Florida, United States, 33781
United States, Indiana
Pfizer Investigational Site
Fort Wayne, Indiana, United States, 46804
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201-1595
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
Pfizer Investigational Site
Portage, Michigan, United States, 49002
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08901
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11220
Pfizer Investigational Site
Elmhurst, New York, United States, 11373
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28203-5871
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38103
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina
Australia, New South Wales
Pfizer Investigational Site
Liverpool, New South Wales, Australia, 2170
Pfizer Investigational Site
New Lambton, New South Wales, Australia, 2305
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Brazil
Pfizer Investigational Site
Cerequeira Cesar, Sao Paolo, Brazil, 05403-010
Pfizer Investigational Site
Vila Clemetino, Sao Paulo, Brazil, 04020-060
Canada, Ontario
Pfizer Investigational Site
Ajax, Ontario, Canada, L1S 2J4
Pfizer Investigational Site
Oshawa, Ontario, Canada, L1G 2B9
Pfizer Investigational Site
Scarborough, Ontario, Canada, M1E 4B9
Pfizer Investigational Site
Windsor, Ontario, Canada, N8W 1L9
Pfizer Investigational Site
Windsor, Ontario, Canada, N9A 1E1
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H4J 1C5
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Finland
Pfizer Investigational Site
Oulu, Finland, 90020
Pfizer Investigational Site
Turku, Finland, FIN-20520
France
Pfizer Investigational Site
Angers, France, 49100
Pfizer Investigational Site
Créteil, France, 94010
Pfizer Investigational Site
Marseille, France, 13009
Pfizer Investigational Site
Toulouse, France, 31400
Germany
Pfizer Investigational Site
Berlin, Germany, 13353
Pfizer Investigational Site
Mainz, Germany, D-55101
Pfizer Investigational Site
Muenster, Germany, 48149
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500063
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380006
Pfizer Investigational Site
Mangalore, Karnataka, India, 575001
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440010
Pfizer Investigational Site
Pune, Maharashtra, India, 411001
Latvia
Pfizer Investigational Site
Riga, Latvia, LV 1001
Pfizer Investigational Site
Riga, Latvia, LV 1005
Mexico
Pfizer Investigational Site
Col. Los Morales, Del Miguel, Hidalgo, Mexico, 11520
Pfizer Investigational Site
Col. el Retiro, Guadalajara, Jal., Mexico, 44280
Pfizer Investigational Site
Mexico City, Mexico D.F., Mexico, CP 01030
Pfizer Investigational Site
Chihuahua, Mexico, 31020
Pfizer Investigational Site
Guadalajara, Jal, Mexico, CP45235,
Poland
Pfizer Investigational Site
Bielsk Podlaski, Poland, 17-100
Pfizer Investigational Site
Krakow, Poland, 30-901
Romania
Pfizer Investigational Site
Cluj-Napoca, Cluj, Romania, 400132
Pfizer Investigational Site
Bucharest, Romania, 014461
Pfizer Investigational Site
Bucuresti, Romania, 050098
Pfizer Investigational Site
Bucuresti, Romania, 014461
Pfizer Investigational Site
Bucuresti, Romania, 021659
Pfizer Investigational Site
Iasi, Romania, 700483
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11000
Pfizer Investigational Site
Nis, Serbia, 18000
Slovenia
Pfizer Investigational Site
Ljubljana, Slovenia, 1000
Spain
Pfizer Investigational Site
Alcala de Henares, Madrid, Spain, 28805
Pfizer Investigational Site
Alcala, Spain, 28805
Pfizer Investigational Site
Madrid, Spain, 28007
Sweden
Pfizer Investigational Site
Uppsala, Sweden, 751 85
United Kingdom
Pfizer Investigational Site
Coventry, United Kingdom, CV2 2DX
Pfizer Investigational Site
Norwich, United Kingdom, NR4 7UY
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 April 16, 2014