CNTX-6970 for Arthrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Arthrosis+2 More
CNTX-6970 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Video Summary

Eligible Conditions
  • Arthrosis
  • Knee

Treatment Effectiveness

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: 24 Weeks

1 Week
Synovial fluid levels of cytokines and chemokines
24 Weeks
Actigraphy
Bedside Quantitative Sensory Testing (QST)
Ecological Momentary Assessment (EMA)
Hospital Anxiety and Depression Scale (HADS)
MCP-1/CCR-2
Numeric Rating Scale (NRS)
PROMIS Sleep Disturbance Scale - 6A
Patient Global Impression of Change (PGIC)
Serum levels of cytokines and chemokines
Staircase-evoked pain assessment
Treatment emergent adverse events (TEAEs)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-C)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Initial Dose Celecoxib 400 mg
5%Beta 2 microglobulin increased
3%Blood bilirubin increased
3%Beta-N-acetyl-D-glucosaminidase increased
2%Eczema
1%Somnolence
1%Post procedural haemorrhage
1%Presyncope
1%Hypoaesthesia facial
1%Blood urine present
1%Urobilin urine present
1%Blood phosphorus decreased
1%Blood creatine phosphokinase increased
1%White blood cell count increased
1%Rash
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT01062113) in the Initial Dose Celecoxib 400 mg ARM group. Side effects include: Beta 2 microglobulin increased with 5%, Blood bilirubin increased with 3%, Beta-N-acetyl-D-glucosaminidase increased with 3%, Eczema with 2%, Somnolence with 1%.

Trial Design

4 Treatment Groups

Active comparator
1 of 4
300mg BID
1 of 4
100mg BID
1 of 4
Placebo
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

150 Total Participants · 4 Treatment Groups

Primary Treatment: CNTX-6970 · Has Placebo Group · Phase 2

300mg BID
Drug
Experimental Group · 1 Intervention: CNTX-6970 · Intervention Types: Drug
100mg BID
Drug
Experimental Group · 1 Intervention: CNTX-6970 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Active comparator
Drug
ActiveComparator Group · 1 Intervention: Celecoxib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

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

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
I can understand the nature of the study and the protocol requirements, and I am willing to comply with the study drug administration requirements and discontinue any prohibited concomitant medications.
Both knees were radiographed using a posterior-anterior, fixed-flexion view during the Screening visit
There was no significant difference in improvement between those who received adequate and inadequate responses to treatment
The subject has moderate to severe pain in the Index knee, which is associated with OA and has been stable for a minimum of 6 months prior to Screening, in the opinion of the investigator.
The index knee has been assessed and found to meet the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis.
managements Unacceptable adverse events can occur during management.
People in the age group of 45 to 80 years old.
willing to use a mobile phone during the study period
Agrees to have any information obtained from the study used for research purposes
The subject can communicate with the site personnel, complete subject-reported outcome measures, and be rated on assessment scales.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Massachusetts33.3%
Wisconsin33.3%
Washington33.3%
How old are they?
18 - 6566.7%
65+33.3%
What site did they apply to?
Massachusetts General Hospital33.3%
University of Washington33.3%
University of Wisconsin- Madison33.3%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References