Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00243295
First received: October 19, 2005
Last updated: October 5, 2006
Last verified: October 2006

October 19, 2005
October 5, 2006
November 2003
Not Provided
  • 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.
  • Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
  • Feasibility measures include
  • 1)Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
  • 2)Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.
Complete list of historical versions of study NCT00243295 on ClinicalTrials.gov Archive Site
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.
Same as current
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Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Osteoarthritis
Drug: rhBMP-2/CPM
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
March 2005
Not Provided

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.

Both
45 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00243295
3100N7-110
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Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP