A study to compare the comfort and ease of use of 5 different treatment regimens for trans-capsaicin injection into the knee in patients with moderate to severe osteoarthritis knee-pai
- Conditions
- The index knee must show evidence of chronic OA with a K-L grade of 1, 2, 3 or 4.MedDRA version: 20.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2018-003094-10-ES
- Lead Sponsor
- Centrexion Therapeutics Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 850
A subject will be eligible for study participation if the subject meets all of the following criteria:
1. Male or female subjects between 40 and 95 years of age (inclusive).
2. Confirmation of OA of the knee: radiography of both knees using standard standing films (scored by the investigator) or using the fixed flexion method, taken during the Screening Visit (prior radiographs of the knees of sufficient quality that have been taken within 2 years of the Screening Visit may be used for K-L grading). The index knee must show evidence of chronic OA with a K-L grade of 1, 2, 3 or 4. . Subjects who were screen failures for the US CNTX-4975i-OA-301 or CNTX-4975i-OA- 304 trials may be considered for this trial if the K-L grade of the index knee is 1-4, inclusive.
3. Confirmation of OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria (ACR confirmation of bilateral knee OA for subjects who will have bilateral knee injections of CNTX-4975-05).
4. For subjects for monoarticular knee injection, the index knee must have moderate to severe pain (=5 and =9) at screening associated with OA, which must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator. These subjects may have:
a) unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
b) unilateral or bilateral OA, with the index knee having moderate to severe pain and the other knee having had a PJR or TJR within 5 years of the Screening Visit. The knee with the PJR/TJR is not to be injected with CNTX-4975-05.
For subjects for bilateral knee injection, the index knee must have moderate to severe pain (=5 and =9) at screening associated with OA, and greater pain in the index knee than in the contralateral knee. Their pain must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator. The index knee in these subjects is the one with the worst pain with walking. Where both knees have equal pain with walking, then the knee on the subject’s dominant side will be designated the index knee.
For qualifying knee pain with walking, subjects will use an NPRS (0-10; 0=no pain, 10=worst possible pain) to rate their knee pain with walking (both knees, except knees with PJR/TJR). The PJR/TJR pain should be rated using the NPRS scale, but will not be a qualifying pain score.
5. Body mass index =45 kg/m2.
6. Subjects must have failed 2 or more prior therapies. Failure is deemed to be inadequate relief in the opinion of the investigator. A therapy may be deemed to have been inadequate because of one or more of the following:
a) unacceptable AEs;
b) initial failure to achieve clinically adequate pain relief;
c) initial pain relief that was not maintained; and/or
d) medical condition resulting in contraindication to the standard of care appropriate to the severity of the index knee OA pain.
Therapies” include, but are not limited to, the following: NSAIDs (including topical), opioids, duloxetine, other systemic therapy, IA corticosteroids, IA viscosupplements, physical therapy, bracing, and orthotics.
7. Females not of childbearing potential, defined as post-menopausal for at l
A subject will be excluded from the study if the subject meets any of the following criteria:
1. Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months. Joint replacement of the contralateral knee is permitted for subjects who will not receive an injection in the contralateral (natural) knee. For subjects with bilateral knee OA who will receive an injection into both knees, joint replacement surgery of both knees at any time, or open surgery of the index knee in the past 24 months, is excluded.
2. Prior arthroscopic surgery of the index knee within 6 months of Screening.
3. Any painful conditions of the index knee due to joint disease other than OA. For example, radicular or referred pain involving the index knee or from joint disease other than OA involving the index knee, such as, but not restricted to chondromalacia patellae, inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis), metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, etc.
4. Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness, or subacute/acute pain from injury.
5. Other chronic pain anywhere in the body that requires the use of chronic analgesic medications, including, but not limited to, local painful areas, myofascial pain syndromes, fibromyalgia, genetic, metabolic abnormalities, hematologic, or neuropathic pain.
6. Instability of the index or contralateral knee (e.g., cruciate ligament tear or rupture, significant protruding meniscus, substantial ligamentous laxity, unstable PJR or TJR).
7. Misalignment (>10 degrees varus or valgus) of the index knee on standing.
8. Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging (radiographic, computed tomography, or magnetic resonance imaging).
9. Physical/occupational/chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 15 days of Screening, or need for such therapy during the study.
10. Plans to have surgery, other invasive procedures, or IA injections (other than CNTX-4975-05) for either knee while participating in the study.
11. Current use of opioids for any condition other than for OA of the knees injected with CNTX-4975-05) (maximum dose of 15 mg of hydrocodone [or equivalent] per day).
12. Corticosteroid injection into the index or contralateral knee within 90 days of Screening.
13. Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening.
14. History of allergic reaction to the planned local anesthesia/analgesic regimens, ethylenediaminetetraacetic acid, Kolliphor HS 15, butylated hydroxytoluene, or capsaicin.
15. Presence of any medical condition or unstable health status that, in the judgment of the investigator, might adversely impact the safety of the subject, or the conduct of the study, or negatively affect the resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, or significantly compromise key organ systems. For any question regarding eligibility, it is strongly recommend
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method