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

CompletedPhase 3NCT03660943
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Interventions
Sponsor
Centrexion Therapeutics
Start date
2018-09-09
Primary completion
2020-06-11
Sex
All
Age range
from 40 Years to 95 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
30

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03660943