Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
NCT ID: NCT01133613
Last Updated: 2012-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2010-05-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
0.03 mg/ml BMP-7 or placebo via intraarticular knee injection
Bone morphogenetic protein 7
Single intraarticular injection of BMP-7 or placebo on Day 1
Cohort 2
0.1 mg/ml BMP-7 or placebo via intraarticular knee injection
Bone morphogenetic protein 7
Single intraarticular injection of BMP-7 or placebo on Day 1
Cohort 3
0.3 mg/ml BMP-7 or placebo via intraarticular knee injection
Bone morphogenetic protein 7
Single intraarticular injection of BMP-7 or placebo on Day 1
Interventions
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Bone morphogenetic protein 7
Single intraarticular injection of BMP-7 or placebo on Day 1
Eligibility Criteria
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Inclusion Criteria
* \>40 years
* Radiographic evidence of at least one osteophyte in either knee at screening
Exclusion Criteria
* Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
* Received arthroscopic or open surgery to the index knee within 6 months of screening
* History of joint replacement surgery (index knee).
* Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
* Long acting hyaluronic acid injection of the index knee within 6 months of screening
* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
* History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
* Female subject with reproductive capability.
40 Years
ALL
No
Sponsors
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Stryker Biotech
INDUSTRY
Responsible Party
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Locations
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Florida Medical Research Institute
Gainesville, Florida, United States
Tufts Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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09-OA-003
Identifier Type: -
Identifier Source: org_study_id
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