An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX-4975-05 Intra-articular Injection in Subjects With Chronic, Moderate-to-Severe Osteoarthritis Knee Pain
1 other identifier
interventional
854
1 country
28
Brief Summary
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 knee-osteoarthritis
Started Sep 2018
Shorter than P25 for phase_3 knee-osteoarthritis
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedStudy Start
First participant enrolled
September 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2019
CompletedResults Posted
Study results publicly available
March 9, 2022
CompletedMarch 9, 2022
January 1, 2022
1.1 years
August 28, 2018
January 4, 2022
February 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction
A composite score was calculated for each of the 5 treatment regimens by summing the scores of three assessments: (1) procedure pain 30 minutes after injection of CNTX-4975-05 on a 0-4 scale, 0 was best indicating no procedure pain, 4 was worst indicating severe procedure pain; (2) assessment of subjects' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best; and (3) assessment of investigators' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best. The procedure pain at 30 minutes was reversed to a 1-7 scale so 7 was best indicating no procedure pain and 1 was worst indicating severe procedure pain. The three assessments were summed for a total score from 3-21, 3 being the worst outcome and 21 being the best outcome. The geometric mean of the scores was derived for each group. All assessments were administered on Day 1 (Baseline).
Day 1 assessments
Secondary Outcomes (7)
Mean Change From Baseline in KOOS "Symptoms" Subscale Score by Subject Type
Baseline, Week 8
Mean Change From Baseline in KOOS "Pain" Subscale Score by Subject Type
Baseline, Week 8
Mean Change From Baseline in KOOS "Pain With Walking" Single Question Score by Subject Type
Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Daily Living)" Subscale Score by Subject Type
Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Sport and Recreational Activities)" Subscale Score by Subject Type
Baseline, Week 8
- +2 more secondary outcomes
Study Arms (5)
Breg Cooling Control Group
EXPERIMENTALSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.
Gel Pack Cooling Group
EXPERIMENTALSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Shortened Gel Pack Cooling Group
EXPERIMENTALSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine
EXPERIMENTALSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine
EXPERIMENTALSubject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Interventions
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
15 mL lidocaine intra-articular injection
Cooling Device
Eligibility Criteria
You may qualify if:
- Male or female subjects between 40 and 95 years of age (inclusive)
- Confirmation of osteoarthritis (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 of CNTX-4975i-OA-301 or CNTX-4975i-OA-304.
- Confirmation of OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
- For subjects for monoarticular knee injection, the index knee must have moderate to severe pain 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:
- unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
- 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 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.
- Body mass index ≤45 kg/m\^2.
You may not qualify if:
- 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.
- 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. 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 disease, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, etc.
- Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness, or subacute/acute pain from injury.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Alabama Orthopaedic Center-Research
Birmingham, Alabama, 35209, United States
Holland Center for Family Health
Peoria, Arizona, 85381, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Med Center Medical Clinic
Carmichael, California, 95608, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Conquest Clinical Research
Maitland, Florida, 32751, United States
F&T Medical Research, Inc.
Miami, Florida, 33184, United States
M&M Medical Center, Inc.
Miami, Florida, 33185, United States
Charter Research
Mt. Dora, Florida, 32757, United States
Premier MED Family & Sports Medicine
Ocoee, Florida, 34761, United States
Ascension Research
Pinellas Park, Florida, 33781, United States
M&M Clinical Trials Sunrise
Sunrise, Florida, 33351, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Atlanta Orthopaedic Institute, LLC
Stockbridge, Georgia, 30281, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422, United States
Affinity Health
Oak Brook, Illinois, 60523, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114, United States
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, 89119, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
First Surgical Hospital
Bellaire, Texas, 77401, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Hermann Drive Surgical Hospital
Houston, Texas, 77004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Centrexion Therapeutics Corporation
Study Officials
- STUDY CHAIR
Randall M. Stevens, MD
Centrexion Therapeutics Corp
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2018
First Posted
September 7, 2018
Study Start
September 18, 2018
Primary Completion
October 22, 2019
Study Completion
October 22, 2019
Last Updated
March 9, 2022
Results First Posted
March 9, 2022
Record last verified: 2022-01