A 24-week Study to Evaluate The Safety and Efficacy of CNTX-6970 in Subjects with Moderate to Severe Knee Osteoarthritis Pain

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Knee Osteoarthritis
  • Age: Between 18 - 95 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Willing to use a mobile device or computer during the study period.
    2. Can understand the nature of the study and protocol requirements and is willing to comply with study drug administration requirements and discontinue prohibited concomitant medications
    3. Provides written informed consent
    4. Is capable of communicating with the site personnel, able to complete subject-reported outcome measures and can be reliably rated on assessment scales
    5. Radiography of both knees with a posterior-anterior, fixed-flexion view taken during the Screening visit
    6. Moderate to severe pain in the Index knee associated with OA and stable for a minimum of 6 months prior to Screening
    7. Confirmation of OA of the index knee
    8. Subjects must have failed 2 or more prior therapies
    9. A summed pain score (0-50) for the Index knee between 25-45 on the WOMAC-A pain subscale
    10. Body mass index (BMI) of = 37 kg/m 2.
    11. Females not of childbearing potential or practicing at least one of the following medically acceptable methods of birth control throughout the study period
    12. Male subjects capable of fathering a child must be willing to use barrier methods to avoid pregnancy during the study
    13. Willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, independently record responses on the pain scales and make daily/weekly entries using the NEForm, and independently communicate meaningfully with study personnel
    14. Willing to refrain from illicit drug use during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study
    15. Subjects must stop taking any current analgesic medications at the time of initial Screening and agree to take only the allowed rescue medication for OA knee pain (acetaminophen; 325mg x 2 tablets PO, QID, PRN) from the time of screening through study completion, and agree to use no topical medications for OA knee pain during the trial
    16. Complete the SAFER (State, Accessibility, Face and Ecological Validity and the Rule of the 3 Ps [persistent, pervasive, pathological]) interview and receive a passing score

You may not be eligible for this study if the following are true:

    1. Any form of joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past
    2. Prior arthroscopic surgery of the index knee within 3 months of Screening
    3. Any painful conditions of the index knee due to joint disease other than OA
    4. Other chronic pain anywhere in the body that is more intense and disabling than index knee pain and that requires the use of analgesic medications
    5. Add Contralateral knee pain equal to or exceeding the pain in the target knee on the WOMAC pain scale
    6. Secondary OA of the index knee due to acute traumatic injury
    7. Significant current or past instability (e.g., cruciate ligament tear or rupture or previous repair) ormisalignment (>10 degrees varus or valgus) of the index knee
    8. Documented history of neuropathic arthropathy
    9. Imaging finding of bony fragmentation in the index knee
    10. Physical/occupational/chiropractic therapy for the lower extremities or acupuncture for the lower extremities
    11. Plans to have surgery, or other invasive procedures, or intra-articular (IA) injections while participating in the study
    12. Current use of opioids
    13. Use of pain medication
    14. Corticosteroid injection in the index knee
    15. Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days
    16. History of clearly documented allergic reaction to the planned active treatment regimens or to celecoxib (Celebrex®), or to sulfa drugs
    17. Knee effusion requiring aspiration of the index or contralateral knee at time of screening
    18. Presence of any medical condition or unstable health status that, in the judgment of the investigator, might adversely affect the safety of the subject or the conduct of the study, or negatively affect the resulting data
    19. Has a malignancy or has received treatment for malignancy at any time
    20. Ulcer or open wound anywhere on the index knee
    21. Clinically significant abnormal laboratory results
    22. Use of an investigational medication within 30 days of Screening
    23. Has active or historic substance use disorder within the previous year
    24. Has urine drug screen is positive for a substance of abuse
    25. Has moderate to severe depression or anxiety
    26. Pregnant
    27. Has ongoing litigation for workers compensation
    28. Has any condition, or is taking any medication, that would be contraindicated for study participation
    29. Known history or symptoms of long QT syndrome
    30. Has a QRS interval <120 ms and QTcF =460 ms OR has a QRS interval =120 ms and QTcF =480 ms
    31. Has moderate to severe congestive heart failure
    32. Has a history of myocardial infarction
    33. K-L Grade 1 or 4 OA in the index knee
    34. Current therapy with any immunosuppressive therapy, including corticosteroids

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