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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 24 weeks
Awards & highlights

Study 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 days
Treatment ~ 168 months
Follow Up ~24 weeks
This trial's timeline: 18 days for screening, 168 months for treatment, and 24 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
4%
Dysgeusia
3%
Nausea
100%
80%
60%
40%
20%
0%
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

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Maurizio Fava, MDLead Sponsor
3 Previous Clinical Trials
245 Total Patients Enrolled

Media Library

CNTX-6970 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05025787 — Phase 2
Osteoarthritis Research Study Groups: Placebo, 300mg BID
Osteoarthritis Clinical Trial 2023: CNTX-6970 Highlights & Side Effects. Trial Name: NCT05025787 — Phase 2
CNTX-6970 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025787 — Phase 2
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05025787 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study enrolling elderly people aged 75 and above?

"Applicants aged 4 to 80 can qualify for this trial. There are 46 separate trials available specifically for minors, while 682 clinical studies exist that cater to individuals over 65 years of age."

Answered by AI

To what extent is the current clinical trial populated?

"This medical study requires 150 individuals with the appropriate qualifications. Participants can join from multiple sites, for instance Medical University of South carolina in Charleston and UTsouthwestern Medical Center in Dallas."

Answered by AI

How has CNTX-6970 been deployed to benefit patients?

"CNTX-6970 is a common prescription for treating pain and also has some efficacy in regards to primary dysmenorrhoea, rheumatoid arthritis, and ankylosing spondylitis."

Answered by AI

Has CNTX-6970 obtained regulatory authorization from the FDA?

"As this is currently a Phase 2 trial, with ample safety data but no evidence of efficacy yet, our team at Power assigned CNTX-6970 a score of 2."

Answered by AI

Has CNTX-6970 been tested in any previous research studies?

"First tested in 2003 by the City of Hope Medical Group Inc, CNTX-6970 has since gone through 18496 clinical trials. At present, 40 are actively enrolling patients with numerous operating out of Charleston, South carolina."

Answered by AI

Are there any opportunities available for those wishing to participate in this experiment?

"Yes, records available on clinicaltrials.gov indicate that recruitment is still ongoing for this trial, which was initially posted on October 25th 2021 and last updated September 21st 2022. 150 participants need to be sourced from 19 different medical sites."

Answered by AI

Am I eligible to join this medical research initiative?

"Prospective participants should suffer from arthrosis and range in age between 4-80 years old if they wish to be admitted into this medical study. A total of 150 individuals are being enrolled."

Answered by AI

What is the aim of this medical research?

"The primary outcome evaluated over the 24-week span of this trial is Treatment emergent adverse events (TEAEs). Secondary objectives encompass Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-C) which assesses daily functioning using an 11-point numerical rating scale, PROMIS Sleep Disturbance Scale - 6A that correlates strongly with longer forms to determine sleep disruption, as well as Patient Global Impression of Change (PGIC), a single-item measure used to estimate treatment associated change."

Answered by AI

How many medical centers are executing this experiment?

"The current recruitment sites for this trial include Medical University of South carolina in Charleston, UTsouthwestern Medical Center in Dallas and the University of California San Diego in La Jolla. In addition to these 3 centres, 19 other clinical facilities are onboarding participants."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Other
Washington
New York
How old are they?
65+
18 - 65
What site did they apply to?
Montefiore Medical Center
Icahn School of Medicine at Mount Sinai
University of Washington
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

Is it a pd trial? When can I come to get started? How long is this trial.What is the compansation from study,and how is it paid?
PatientReceived no prior treatments
Just the obvious …how often to Seattle (I live on Bainbridge) , safety of drug ?
PatientReceived no prior treatments

Why did patients apply to this trial?

I saw them listed on Facebook. I want to get a cure for my pain! I’m in constant pain in my hips and knees.
PatientReceived no prior treatments
I would like to avoid surgery if possible! To get relief and help for pain in my knee!
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. University of Washington: < 24 hours
  2. Icahn School of Medicine at Mount Sinai: < 48 hours
  3. Montefiore Medical Center: < 48 hours
Typically responds via
Email
Phone Call
Recent research and studies
~15 spots leftby Apr 2025