Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
Completed · Phase 1 · Has a placebo group
Conditions studied: Osteoarthritis of the Knee
In brief
The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.
Key facts
- Study ID
- NCT01133613
- Run by
- Stryker Biotech
- People needed
- 51
- Starts
- 2010-05-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2012-02-01
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
- >40 years
- Radiographic evidence of at least one osteophyte in either knee at screening
You may not qualify if…
- Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
- 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.
Where it is running
- Florida Medical Research Institute — Gainesville, Florida, United States
- Tufts Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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