Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Osteoarthritis
In brief
The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.
Key facts
- Study ID
- NCT02800629
- Run by
- Massachusetts General Hospital
- People needed
- 50
- Starts
- 2016-07-01
- Expected to finish
- 2018-06-01
- Last updated by the study team
- 2018-03-23
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Knee pain in at least one knee for more than half the days in the month prior to screening
- X-rays showing evidence of knee osteoarthritis by Kellgren and Lawrence Score two or three, with definite osteophytes and possible or definite joint space narrowing, consistent with mild to moderate knee osteoarthritis. If both knees are affected, patients would choose the more severe knee for outcomes assessments.
- Willingness to maintain stable analgesic regimen throughout the study period
You may not qualify if…
- Diagnosis of fibromyalgia
- Presence of an underlying inflammatory disease in the affected knee, including Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory disease.
- Patients who cannot give consent will be excluded, as will patients who cannot speak, read and understand English, as we will not have translated documents, consent forms, and surveys for them.
- While this supplement is considered very safe and low risk, patients with underlying significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10, or platelets less than 100), or with impaired renal function (glomerular filtration rate less than 60) or elevated liver enzymes will be excluded as well.
Where it is running
- MGH — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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