A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain.

A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain.
Recruiting
40 years - 90 years
All
Phase N/A
8 participants needed
1 Location

Brief description of study

The purpose of this study is to evaluate the safety and efficacy of CNTX-6970. The target population is adults between 40 - 90 years old who have moderate to severe knee pain related to OA. The study drug is being compared to Celebrex, an FDA approved drug used to treat knee OA pain. The study is a double-blind design in which participants are randomized to ONE of the following treatment arms of the study: 300mg CNTX-6970 twice daily, 100mg CNTX-6970 twice daily, or 100mg Celebrex twice daily. Participants will be assigned to only ONE of these medications for the whole duration of the study, and both researchers and participants will not know which of the arms of the study the participant has been assigned to.

Detailed description of study

Study participants will attend roughly 10 visits, about once every 3 weeks for a period of about 6 months. The purpose of these visits is to receive medication, have blood drawn, and perform study activities such as EKG tests and sensory testing. Wearing an activity monitor bracelet for an interval of the time between visits is also required. If you decide to participate, you may be eligible to earn up to $650. All visits will take place at Penn Medicine locations, specifically the Tuttleman Center and Pennsylvania Hospital.

You may NOT be eligible for this study if any of the following conditions apply to you:
     - have received joint replacement surgery, open surgery, or arthroscopic surgery of your knees within the past 12 months.
     - have other pain of the knees or legs not related to OA that is the same or worse intensity as your knee OA pain.
     - have a history of allergic reactions to Celebrex or Sulfa drugs.
     - have a Body mass index (BMI) of > 40 kg/m2. Want to find out your BMI? Calculate it here using your height and weight: BMI Calculator (princetonhcs.org)

Eligibility of study

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

  • Conditions: Osteoarthritis
  • Age: 40 years - 90 years
  • Gender: All


Updated on 04 Aug 2024. Study ID: 849664

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