Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

Phase 3

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Modified Citrus Pectin

• Registration Number: NCT02800629
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-15
• Study Start: 2016-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-23
• Primary Completion: 2018-05
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. 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

1. 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
Intervention	Modified Citrus Pectin	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

Primary Outcome Measures

Name	Time	Method
WOMAC-Knee	12 weeks

Trial Locations

Locations (1)

MGH; 🇺🇸 Boston, Massachusetts, United States