Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02800629
• Other study ID #: 2016P001077
• Status: Recruiting
• Phase: Phase 3
• First received: June 7, 2016
• Last updated: March 22, 2018
• Start date: July 2016
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Massachusetts General Hospital
• Contact: Yousif Hanna
• Phone: 6177267938
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• Modified Citrus Pectin
MCP versus placebo
• Placebo

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC-Knee		12 weeks