Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Modified Citrus Pectin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- MGHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
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
Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
Outcomes
Primary Outcome Measures
WOMAC-Knee
Secondary Outcome Measures
Full Information
NCT ID
NCT02800629
First Posted
June 7, 2016
Last Updated
March 22, 2018
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02800629
Brief Title
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Official Title
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified Citrus Pectin
Intervention Description
MCP versus placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
WOMAC-Knee
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yousif Hanna
Phone
6177267938
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Fernandes
Phone
6177267938
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Fisher
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth Brownmiller
Phone
617-726-7938
First Name & Middle Initial & Last Name & Degree
Ana Fernandes
Phone
6177267938
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
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