Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

NCT02800629 | Unknown Phase 3

• 1 other identifier: 2016P001077
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC-Knee

  12 weeks

Study Arms (2)

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

Dietary Supplement: Modified Citrus Pectin

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

Dietary Supplement: Placebo

Interventions

Modified Citrus Pectin DIETARY_SUPPLEMENT

MCP versus placebo

Intervention

Placebo DIETARY_SUPPLEMENT

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

citrus pectin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mark Fisher

  MGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousif Hanna

CONTACT

6177267938

Ana Fernandes

CONTACT

6177267938

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, HMS

Model Details: Randomized, double blind clinical trial

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 15, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)