A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

Study Purpose

This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 95 Years
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study- provided tablet computers.

- Confirmation of osteoarthritis (OA) of the knee.

- Confirmation of the OA of the index knee.

- Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.

- Body Mass Index (BMI) ≤45 kg/m^2 - Must have failed 2 or more prior therapies.

Exclusion Criteria:

- Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.

- Prior arthroscopic surgery of the index knee within 6 months of Screening.

- Any painful conditions of the index knee due to joint disease other than the OA.

- Periarticular pain from any cause.

- Other chronic pain anywhere in the body that requires the use of analgesic medications.

- Instability of the index knee.

- Misalignment (>10 degrees varus or valgus) of the index knee on standing.

- Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.

- Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.

- Plans to have surgery, other invasive procedures, or IA injections while participating in the study.

- Has used topical capsaicin on the index knee within 90 days of Screening.

- Current use of opioids for any condition other than for OA of the index knee.

- Corticosteroid injection into the index knee within 90 days of Screening.

- Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03660943
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centrexion Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Randall Stevens, MD
Principal Investigator Affiliation	Centrexion Therapeutics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lillestol Research LLC, Fargo, North Dakota

Status

Recruiting

Address

Lillestol Research LLC

Fargo, North Dakota, 58104

Site Contact

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