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Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

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NCT00243295

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00243295
Pfizer
Completed
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

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Pfizer Clinical Trials Contact Center

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[email protected]

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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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Osteoarthritis
Drug: rhBMP-2/CPM
Not Provided
Not Provided


*   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.
Sexes Eligible for Study: All
45 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00243295
3100N7-110
Not Provided
Not Provided
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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