NCT02800629UnknownPhase 3
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Massachusetts General Hospital2 sites in 1 country50 target enrollmentStarted: July 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- WOMAC-Knee
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Intervention
Active Comparator
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
Intervention: Modified Citrus Pectin (Dietary Supplement)
Control
Placebo Comparator
Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
WOMAC-Knee
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Mark C Fisher
Instructor, HMS
Massachusetts General Hospital
Study Sites (2)
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