Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Purpose
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.
Condition
- Osteoarthritis
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Knee pain in at least one knee for more than half the days in the month prior to screening 2. 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. 3. Willingness to maintain stable analgesic regimen throughout the study period
Exclusion Criteria
- Diagnosis of fibromyalgia 2. Presence of an underlying inflammatory disease in the affected knee, including Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory disease. 3. 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. 4. 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, double blind clinical trial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Intervention |
Patients will be given Modified Citrus Pectin twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed |
|
Placebo Comparator Control |
Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed |
|
Recruiting Locations
MGH
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Seth Brownmiller
617-726-7938
Seth Brownmiller
617-726-7938
More Details
- Status
- Unknown status
- Sponsor
- Massachusetts General Hospital
Study Contact
Yousif Hanna6177267938