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Clinical Trials/NCT02800629
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mark C Fisher

Instructor, HMS

Massachusetts General Hospital

Study Sites (2)

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