Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

Wyeth

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis

Treatments

Drug: rhBMP-2/CPM

Study type

Interventional

Funder types

Industry

Identifiers

3100N7-110

Details and patient eligibility

About

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.

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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.