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

NCT00387686 | Terminated Phase 2

• 1 other identifier: 3100N7-210
• Study Type: interventional
• Target: 367
• Locations: 17 countries
• Sites: 66

Brief Summary

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.

Conditions

Fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra

Secondary Outcomes (1)

• Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months

  12 months

Study Arms (4)

A

EXPERIMENTAL

1.0 mg/mL rhBMP-2/CPM + surgical fixation

Drug: rhBMP-2/CPM

B

EXPERIMENTAL

2.0 mg/mL rhBMP-2/CPM + surgical fixation

Drug: rhBMP-2/CPM

C

ACTIVE COMPARATOR

Buffer/CPM + surgical fixation Intervention

Drug: rhBMP-2/CPM

D

OTHER

Standard of Care: Surgical fixation intervention

Drug: rhBMP-2/CPM

Interventions

rhBMP-2/CPM DRUG

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (68)

Pfizer Investigational Site

Birmingham, Alabama, 35294-3708, United States

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Birmingham, Alabama, 35294, United States

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Aurora, Colorado, 80012, United States

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Denver, Colorado, 80204, United States

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New Haven, Connecticut, 06519, United States

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Pinellas Park, Florida, 33781, United States

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Fort Wayne, Indiana, 46804, United States

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Indianapolis, Indiana, 46202, United States

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Baltimore, Maryland, 21201-1595, United States

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Kalamazoo, Michigan, 49007, United States

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Portage, Michigan, 49002, United States

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Lebanon, New Hampshire, 03756, United States

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New Brunswick, New Jersey, 08901, United States

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Brooklyn, New York, 11220, United States

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Elmhurst, New York, 11373, United States

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Charlotte, North Carolina, 28203-5871, United States

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Memphis, Tennessee, 38103, United States

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Buenos Aires, Argentina

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Liverpool, New South Wales, 2170, Australia

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New Lambton, New South Wales, 2305, Australia

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Cerequeira Cesar, São Paulo, 05403-010, Brazil

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Vila Clemetino, São Paulo, 04020-060, Brazil

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Ajax, Ontario, L1S 2J4, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Scarborough Village, Ontario, M1E 4B9, Canada

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Windsor, Ontario, N8W 1L9, Canada

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Windsor, Ontario, N9A 1E1, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Oulu, 90020, Finland

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Turku, FIN-20520, Finland

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Angers, 49100, France

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Créteil, 94010, France

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Marseille, 13009, France

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Toulouse, 31400, France

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Berlin, 13353, Germany

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Mainz, D-55101, Germany

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Münster, 48149, Germany

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Hyderabad, Andhra Pradesh, 500063, India

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Ahmedabad, Gujarat, 380006, India

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Mangalore, Karnataka, 575001, India

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Nagpur, Maharashtra, 440010, India

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Pune, Maharashtra, 411001, India

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Riga, LV 1001, Latvia

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Riga, LV 1005, Latvia

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Chihuahua City, Chihuahua, 31020, Mexico

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Col. Los Morales, Del Miguel, Hidalgo, 11520, Mexico

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Col. El Retiro, Guadalajara, Jal., 44280, Mexico

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Mexico City, Mexico City, CP 01030, Mexico

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Guadalajara, Jal, CP45235,, Mexico

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Bielsk Podlaski, 17-100, Poland

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Krakow, 30-901, Poland

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Cluj-Napoca, Cluj, 400132, Romania

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Iași, Iaşi, 700483, Romania

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Bucharest, 014461, Romania

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Bucharest, 021659, Romania

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Bucharest, 050098, Romania

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Belgrade, 11000, Serbia

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Niš, 18000, Serbia

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Ljubljana, 1000, Slovenia

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Alcalá de Henares, Madrid, 28805, Spain

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Madrid, Madrid, 28007, Spain

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Alcalá, 28805, Spain

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Uppsala, 751 85, Sweden

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Coventry, CV2 2DX, United Kingdom

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Norwich, NR4 7UY, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 13, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2010
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

BR (2); AU (4); SE (1); PL (2); IN (5); DE (3); SL (1); US (17); AR (1); FR (4); ES (3); GB (2); LA (2); CA (7); RO (5); FI (2); ME (5)