OsteoarthritisPhase 3NCT02800629
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
A Phase 3 study testing Modified Citrus Pectin in people with Osteoarthritis, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Modified Citrus Pectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yousif Hanna contact
Ana Fernandes contact
United States1 site, 1 recruiting
- Recruiting
MGH
Boston, Massachusetts, 02114
Seth Brownmiller, 617-726-7938
Ana Fernandes, 6177267938
About this study
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
- Being tested
- Modified Citrus Pectin, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Citrus PectinDietary supplement
MCP versus placebo
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC-Knee
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark C Fisher, Massachusetts General Hospital
- Investigators
- Mark Fisher, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800629
- Sponsor's protocol ID
- 2016P001077
- Status last verified
- Mar 2018
- First submitted
- 7 Jun 2016
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02800629
- Acronym / sponsor ID
- 2016P001077
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Modified Citrus PectinPatients will be given Modified Citrus Pectin twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed |
| Control | Placebo comparator | Dietary Supplement: PlaceboPatients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Citrus PectinMCP versus placebo | Dietary supplement | Intervention |
| Placebo | Dietary supplement | Control |
Primary outcome
WOMAC-Knee
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified Citrus Pectin in people with Osteoarthritis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousif Hanna (6177267938), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC-Knee (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.