- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243295
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
October 5, 2006 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies
To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:
- Injecting the desired volume of rhBMP-2/CPM within the defect
- Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.
Study Overview
Study Type
Interventional
Enrollment
6
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects 45 to 70 years of age
- Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
- Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.
Other inclusion applies.
Exclusion Criteria:
- Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
- Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
- Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.
Other exclusion applies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
|
Feasibility measures include
|
Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
|
Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
October 19, 2005
First Submitted That Met QC Criteria
October 19, 2005
First Posted (Estimate)
October 21, 2005
Study Record Updates
Last Update Posted (Estimate)
October 6, 2006
Last Update Submitted That Met QC Criteria
October 5, 2006
Last Verified
October 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3100N7-110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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