What side effects are associated with this type of intervention?

Common treatments for osteoarthritis pain, such as NSAIDs (e.g., ibuprofen, naproxen), can cause gastrointestinal issues, cardiovascular risks, and renal problems. Glucocorticoids, used for their anti-inflammatory effects, may lead to joint infection, increased blood sugar levels, and osteoporosis with long-term use. Duloxetine, an antidepressant used for pain management, can cause nausea, dry mouth, and fatigue. Anti-NGF agents like tanezumab and fasinumab have shown efficacy in pain reduction but are associated with risks of rapidly progressive OA and nervous system effects.

What prior FDA approvals exist?

FDA-approved treatments for osteoarthritis pain management include NSAIDs like ibuprofen, naproxen, and celecoxib, which are effective for pain relief. Anti-NGF agents such as tanezumab and fasinumab have also been studied, showing potential in reducing pain and improving function, though tanezumab was discontinued due to safety concerns. CNTX-6970 is currently under investigation for its safety and efficacy in treating knee osteoarthritis pain.

What other types of research exist?

Promising novel alternatives to CNTX-6970 for osteoarthritis of the knee include: 1) Lorecivivint (LOR; SM04690), a Wnt pathway modulator, which has shown improvements in patient-reported and radiographic outcomes. 2) Fulranumab, a monoclonal antibody targeting nerve growth factor (NGF), which has demonstrated efficacy in reducing chronic knee pain. 3) Tanezumab, another NGF inhibitor, which has shown significant pain reduction in phase III trials. 4) ONO-4474, a pan-tropomyosin receptor kinase inhibitor, which has shown efficacy in reducing knee pain in patients refractory to NSAIDs.

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CNTX-6970 for Knee Osteoarthritis Pain

Verified Trial

Phase 2

Recruiting

Research Sponsored by Maurizio Fava, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals between 40 and 90 years of age (inclusive) at the time of the Screening Visit.

Willing to use a mobile smart device during the study period. Individuals who do not have access to a mobile device will be provided with one for the duration of the study and trained in its use.

Must not have

Have you received a corticosteroid injection within the past 30 days ?

Timeline

Screening 18 days

Treatment 168 months

Follow Up 0 weeks

Awards & highlights

Summary

This trial is testing a new pain medication for people with osteoarthritis of the knee. The goal is to see if it is safe and effective.

Who is the study for?

Adults aged 40-90 with a BMI of ≤ 40 kg/m2, suffering from moderate to severe knee pain due to osteoarthritis for at least 6 months. Participants must have tried and found inadequate relief from at least two prior therapies, agree to drug testing, use a mobile smart device during the study, and not have other conditions causing similar pain.Check my eligibility

What is being tested?

The trial is testing CNTX-6970's safety and effectiveness in relieving chronic knee pain caused by osteoarthritis compared to a placebo. It aims to see if this new treatment can improve patients' condition who haven't responded well to previous treatments.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to CNTX-6970 or placebo during the trial period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 40 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had a corticosteroid injection in the last 30 days.

Timeline

Screening ~ 18 days1 visit

Treatment ~ 168 months8 visits

Follow Up ~ 0 weeks9 visits

Screening ~ 18 days

Treatment ~ 168 months

Follow Up ~0 weeks

This trial's timeline: 18 days for screening, 168 months for treatment, and 0 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment emergent adverse events (TEAEs)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)

Secondary outcome measures

Hospital Anxiety and Depression Scale (HADS)

MCP-1/CCR-2

Numeric Rating Scale (NRS)

+5 more

Side effects data

From 2019 Phase 3 trial • 622 Patients • NCT03006276

Dysgeusia

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

DFN-15 DB1

Placebo DB2

Placebo DB1

DFN-15 DB2

Overall

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 300mg BIDExperimental Treatment1 Intervention

The higher dose (i.e., 300mg BID) demonstrated good tolerability and safety, as well as over 90% inhibition of the binding of monocyte chemoattractant protein-1 to its CCR-2 receptor. Moreover, this dose produced nearly 90% binding inhibition at the CCR-5 receptor as well.

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CNTX-6970

2017

Completed Phase 1

~70

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) primarily target pain relief and improving joint function. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the inflammatory process. Duloxetine, an antidepressant, works by increasing serotonin and norepinephrine levels in the brain, which can help modulate pain perception. Non-pharmacologic therapies, such as physical exercise, improve joint mobility and strength, while psychological interventions like cognitive behavioral therapy (CBT) help patients manage pain through coping strategies. These treatments are crucial for OA patients as they address both the physical and psychological aspects of chronic pain, enhancing overall quality of life.