Status:
COMPLETED
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Osteoarthritis
Eligibility:
All Genders
45-70 years
Phase:
PHASE1
Brief Summary
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 withi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00243295
Start Date
November 1 2003
End Date
March 1 2005
Last Update
October 6 2006
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.