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

Primary Purpose

Fractures

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rhBMP-2/CPM
rhBMP-2/CPM
rhBMP-2/CPM
rhBMP-2/CPM
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Other

Arm Label

A

B

C

D

Arm Description

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

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

Buffer/CPM + surgical fixation Intervention

Standard of Care: Surgical fixation intervention

Outcomes

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.

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

Full Information

First Posted
October 11, 2006
Last Updated
February 21, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00387686
Brief Title
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Arm Title
B
Arm Type
Experimental
Arm Description
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Arm Title
C
Arm Type
Active Comparator
Arm Description
Buffer/CPM + surgical fixation Intervention
Arm Title
D
Arm Type
Other
Arm Description
Standard of Care: Surgical fixation intervention
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3708
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Pfizer Investigational Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Pfizer Investigational Site
City
Portage
State/Province
Michigan
ZIP/Postal Code
49002
Country
United States
Facility Name
Pfizer Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Pfizer Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Pfizer Investigational Site
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203-5871
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos Aires
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Pfizer Investigational Site
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Pfizer Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Cerequeira Cesar
State/Province
Sao Paolo
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Vila Clemetino
State/Province
Sao Paulo
ZIP/Postal Code
04020-060
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1E 4B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1L9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
90020
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
FIN-20520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Pfizer Investigational Site
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
D-55101
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500063
Country
India
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Pfizer Investigational Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Pfizer Investigational Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
LV 1001
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
LV 1005
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Col. Los Morales
State/Province
Del Miguel, Hidalgo
ZIP/Postal Code
11520
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Col. el Retiro
State/Province
Guadalajara, Jal.
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico City
State/Province
Mexico D.F.
ZIP/Postal Code
CP 01030
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Chihuahua
ZIP/Postal Code
31020
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Guadalajara, Jal
ZIP/Postal Code
CP45235,
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Bielsk Podlaski
ZIP/Postal Code
17-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Krakow
ZIP/Postal Code
30-901
Country
Poland
Facility Name
Pfizer Investigational Site
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400132
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucharest
ZIP/Postal Code
014461
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
021659
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Pfizer Investigational Site
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Pfizer Investigational Site
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alcala
ZIP/Postal Code
28805
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3100N7-210&StudyName=A%20Phase%202/3%20Multicenter%2C%20Controlled%20Trial%20Of%20rhBMP-2/CPM%20In%20Tibial%20Fractures
Description
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A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

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