FracturesPhase 2/3NCT00387686
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
A Phase 2/3 study testing rhBMP-2/CPM in people with Fractures, run by Wyeth is now a wholly owned subsidiary of Pfizer at 68 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures
- What is being tested?
- rhBMP-2/CPM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 68 sitesin 18 countries
- Study dates
- Nov 2006to Mar 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
68 sites in 18 countries.
68 sites in 18 countries
United States17 sites
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Baltimore, Maryland, 21201-1595
Pfizer Investigational Site
Birmingham, Alabama, 35294-3708
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Brooklyn, New York, 11220
Pfizer Investigational Site
Charlotte, North Carolina, 28203-5871
Pfizer Investigational Site
Denver, Colorado, 80204
Pfizer Investigational Site
Elmhurst, New York, 11373
Pfizer Investigational Site
Fort Wayne, Indiana, 46804
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Memphis, Tennessee, 38103
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Haven, Connecticut, 06519
Pfizer Investigational Site
Pinellas Park, Florida, 33781
Pfizer Investigational Site
Portage, Michigan, 49002
Canada7 sites
Pfizer Investigational Site
Ajax, Ontario, L1S 2J4
Pfizer Investigational Site
Montreal, Quebec, H4J 1C5
Pfizer Investigational Site
Oshawa, Ontario, L1G 2B9
Pfizer Investigational Site
Scarborough Village, Ontario, M1E 4B9
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
Windsor, Ontario, N8W 1L9
Pfizer Investigational Site
Windsor, Ontario, N9A 1E1
India5 sites
Pfizer Investigational Site
Ahmedabad, Gujarat, 380006
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500063
Pfizer Investigational Site
Mangalore, Karnataka, 575001
Pfizer Investigational Site
Nagpur, Maharashtra, 440010
Pfizer Investigational Site
Pune, Maharashtra, 411001
Mexico5 sites
Pfizer Investigational Site
Chihuahua City, Chihuahua, 31020
Pfizer Investigational Site
Col. El Retiro, Guadalajara, Jal., 44280
Pfizer Investigational Site
Col. Los Morales, Del Miguel, Hidalgo, 11520
Pfizer Investigational Site
Guadalajara, Jal, CP45235,
Pfizer Investigational Site
Mexico City, Mexico City, CP 01030
Romania5 sites
Pfizer Investigational Site
Bucharest, 014461
Pfizer Investigational Site
Bucharest, 021659
Pfizer Investigational Site
Bucharest, 050098
Pfizer Investigational Site
Cluj-Napoca, Cluj, 400132
Pfizer Investigational Site
Iași, Iaşi, 700483
Australia4 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
Liverpool, New South Wales, 2170
Pfizer Investigational Site
New Lambton, New South Wales, 2305
France4 sites
Pfizer Investigational Site
Angers, 49100
Pfizer Investigational Site
Créteil, 94010
Pfizer Investigational Site
Marseille, 13009
Pfizer Investigational Site
Toulouse, 31400
Germany3 sites
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Mainz, D-55101
Pfizer Investigational Site
Münster, 48149
Spain3 sites
Pfizer Investigational Site
Alcalá, 28805
Pfizer Investigational Site
Alcalá de Henares, Madrid, 28805
Pfizer Investigational Site
Madrid, Madrid, 28007
Brazil2 sites
Pfizer Investigational Site
Cerequeira Cesar, São Paulo, 05403-010
Pfizer Investigational Site
Vila Clemetino, São Paulo, 04020-060
Finland2 sites
Pfizer Investigational Site
Oulu, 90020
Pfizer Investigational Site
Turku, FIN-20520
Latvia2 sites
Pfizer Investigational Site
Riga, LV 1001
Pfizer Investigational Site
Riga, LV 1005
Poland2 sites
Pfizer Investigational Site
Bielsk Podlaski, 17-100
Pfizer Investigational Site
Krakow, 30-901
Serbia2 sites
Pfizer Investigational Site
Belgrade, 11000
Pfizer Investigational Site
Niš, 18000
United Kingdom2 sites
Pfizer Investigational Site
Coventry, CV2 2DX
Pfizer Investigational Site
Norwich, NR4 7UY
About this study
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
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
- Being tested
- rhBMP-2/CPM
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBMP-2/CPMDrug
rhBMP-2/CPMDrug
rhBMP-2/CPMDrug
rhBMP-2/CPMDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 1.0 mg/mL rhBMP-2/CPM + surgical fixation Receives: Drug: rhBMP-2/CPM |
| B | Experimental | 2.0 mg/mL rhBMP-2/CPM + surgical fixation Receives: Drug: rhBMP-2/CPM |
| C | Active comparator | Buffer/CPM + surgical fixation Intervention Receives: Drug: rhBMP-2/CPM |
| D | Other | Standard of Care: Surgical fixation intervention Receives: Drug: rhBMP-2/CPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2009
- Study completionMar 2010
Why it stopped: Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387686
- Sponsor's protocol ID
- 3100N7-210
- Status last verified
- Feb 2013
- First submitted
- 11 Oct 2006
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00387686
- Acronym / sponsor ID
- 3100N7-210
- Conditions
- Fractures
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: rhBMP-2/CPM1.0 mg/mL rhBMP-2/CPM + surgical fixation |
| B | Experimental | Drug: rhBMP-2/CPM2.0 mg/mL rhBMP-2/CPM + surgical fixation |
| C | Active comparator | Drug: rhBMP-2/CPMBuffer/CPM + surgical fixation Intervention |
| D | Other | Drug: rhBMP-2/CPMStandard of Care: Surgical fixation intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhBMP-2/CPM | Drug | A |
| rhBMP-2/CPM | Drug | B |
| rhBMP-2/CPM | Drug | C |
| rhBMP-2/CPM | Drug | D |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
68 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rhBMP-2/CPM in people with Fractures, run by Wyeth is now a wholly owned subsidiary of Pfizer at 68 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Canada, India, Mexico, Romania and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.