A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
- Registration Number
- NCT03429049
- Lead Sponsor
- Centrexion Therapeutics
- Brief Summary
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
- 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 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.
- BMI ≤45 kg/m^2.
- Must have failed 2 or more prior therapies.
- Females not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile, or practicing one of the following medically acceptable methods of birth control throughout the study period.
- Subject agrees to stay on their current pain medication (including over the counter (OTC) medications) from the time of Screening through Week 12. The current pain medication must be taken only for pain in the index knee, and not for another pain indication.
- Subject agrees to take only the allowed rescue medications for OA knee pain of the index knee from the time of Screening through study completion and agrees to use no topical medications for OA knee pain during the trial.
Key
- 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 OA.
- Periarticular pain from any cause.
- Pain in the non-index knee that is >3 on a numeric pain rating scale (NPRS) (0-10) when walking or at rest.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo of 2.0 mL for IA injection CNTX-4975-05 CNTX-4975-05 Pre-filled glass syringes administered as a single 2.0 mL IA injection
- Primary Outcome Measures
Name Time Method Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee Baseline, Week 12 Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score.
Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score Baseline, Week 12 The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).
The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.
The stiffness dimension has 2 items: joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20.Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score Baseline, Week 12 The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).
The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.
The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score Baseline, Week 12 The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).
The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.
The function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170.
Trial Locations
- Locations (33)
Clinical Research Consortium
🇺🇸Las Vegas, Nevada, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Clinical Investigations of Texas
🇺🇸Plano, Texas, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
M&M Medical Center, Inc
🇺🇸Miami, Florida, United States
Alabama Orthopaedic Center - Research
🇺🇸Birmingham, Alabama, United States
Tampa Bay Medical Research, Inc
🇺🇸Clearwater, Florida, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
Cahaba Research, Inc
🇺🇸Birmingham, Alabama, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Coastal Clinical Research, Inc
🇺🇸Mobile, Alabama, United States
Biosolutions Clinical Research Center
🇺🇸La Mesa, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Mid America PolyClinic
🇺🇸Overland Park, Kansas, United States
Atlanta Orthopaedic Institute, LLC
🇺🇸Stockbridge, Georgia, United States
Georgia Institute for Clinical Research, LLC
🇺🇸Marietta, Georgia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Medical Research Associates, Inc
🇺🇸Traverse City, Michigan, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Tristan Medical Enterprises PC, dba
🇺🇸North Attleboro, Massachusetts, United States
Bone Joint & Spine Surgeons, Inc
🇺🇸Toledo, Ohio, United States
Ortho Virginia
🇺🇸Arlington, Virginia, United States
Noble Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Jewett Orthopaedic
🇺🇸Orlando, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States