An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA

February 11, 2022 updated by: Centrexion Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a single intra-articular (IA) injection, in one or both knees, of CNTX-4975-05 in subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the investigational product, CNTX-4975-05, will be controlled primarily through adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine.

Study Type

Interventional

Enrollment (Actual)

854

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Alabama Orthopaedic Center-Research
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Holland Center for Family Health
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
    • California
      • Carmichael, California, United States, 95608
        • Med Center Medical Clinic
      • Cerritos, California, United States, 90703
        • Core Healthcare Group
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Maitland, Florida, United States, 32751
        • Conquest Clinical Research
      • Miami, Florida, United States, 33184
        • F&T Medical Research, Inc.
      • Miami, Florida, United States, 33185
        • M&M Medical Center, Inc.
      • Mount Dora, Florida, United States, 32757
        • Charter Research
      • Ocoee, Florida, United States, 34761
        • Premier MED Family & Sports Medicine
      • Pinellas Park, Florida, United States, 33781
        • Ascension Research
      • Sunrise, Florida, United States, 33351
        • M&M Clinical Trials Sunrise
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Institute for Clinical Research, LLC
      • Stockbridge, Georgia, United States, 30281
        • Atlanta Orthopaedic Institute, LLC
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Healthcare Research Network II, LLC
      • Oak Brook, Illinois, United States, 60523
        • Affinity Health
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network
      • Kansas City, Missouri, United States, 64114
        • Center for Pharmaceutical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Office of Robert P. Kaplan, DO
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • Texas
      • Bellaire, Texas, United States, 77401
        • First Surgical Hospital
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research Center
      • Houston, Texas, United States, 77004
        • Hermann Drive Surgical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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:

  1. unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
  2. 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.

Key Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breg Cooling Control Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Other Names:
  • capsaicin
Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
Other Names:
  • Lidocaine
Device: Breg Ice Water Pump
Cooling Device
Experimental: Gel Pack Cooling Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Other Names:
  • capsaicin
Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
Other Names:
  • Lidocaine
Device: ElastoGel
Cooling Device
Experimental: Shortened Gel Pack Cooling Group
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Other Names:
  • capsaicin
Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
Other Names:
  • Lidocaine
Device: ElastoGel
Cooling Device
Experimental: Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine
Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Other Names:
  • capsaicin
Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
Other Names:
  • Lidocaine
Device: ElastoGel
Cooling Device
Experimental: Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine
Subject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel.
Drug: CNTX-4975-05
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Other Names:
  • capsaicin
Drug: Lidocaine without epinephrine
15 mL lidocaine intra-articular injection
Other Names:
  • Lidocaine
Device: ElastoGel
Cooling Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction
Time Frame: Day 1 assessments

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in KOOS "Symptoms" Subscale Score by Subject Type
Time Frame: Baseline, Week 8

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

The KOOS was administered on Day 1 (Baseline) and Week 8.

Higher scores (or positive change from baseline) indicate improvement.
Baseline, Week 8
Mean Change From Baseline in KOOS "Pain" Subscale Score by Subject Type
Time Frame: Baseline, Week 8

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

The KOOS was administered on Day 1 (Baseline) and Week 8.

Higher scores (or positive change from baseline) indicate improvement.
Baseline, Week 8
Mean Change From Baseline in KOOS "Pain With Walking" Single Question Score by Subject Type
Time Frame: Baseline, Week 8

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS Pain with Walking is a single question from the KOOS Pain subscale.

The KOOS was administered on Day 1 (Baseline) and Week 8.

Higher scores (or positive change from baseline) indicate improvement.
Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Daily Living)" Subscale Score by Subject Type
Time Frame: Baseline, Week 8

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

The KOOS was administered on Day 1 (Baseline) and Week 8.

Higher scores (or positive change from baseline) indicate improvement.
Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Sport and Recreational Activities)" Subscale Score by Subject Type
Time Frame: Baseline, Week 8

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

The KOOS was administered on Day 1 (Baseline) and Week 8.

Higher scores (or positive change from baseline) indicate improvement.
Baseline, Week 8
Mean Change From Baseline in KOOS "Knee-Related Quality of Life" Subscale Score by Subject Type
Time Frame: Baseline, Week 8

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

The KOOS was administered on Day 1 (Baseline) and Week 8.

Higher scores (or positive change from baseline) indicate improvement.
Baseline, Week 8
Mean Change From Baseline in Average Daily Pain With Walking NPRS (0-10) Score by Subject Type
Time Frame: Baseline, Week 8

The pain with walking Numerical Pain Rating Scale (NPRS) (0-10, 0 being no pain, 10 being greatest pain) collected subjects' average pain with walking over the past 24 hours. Subjects recorded the pain in their target knee, either the index knee or additionally the non-index knee in the case of bilateral subjects. The NPRS was collected at Day 1 (Baseline) and Week 8.

Lower scores (or negative change from baseline) indicate improvement
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centrexion Therapeutics

Investigators

  • Study Chair: Randall M. Stevens, MD, Centrexion Therapeutics Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2018

Primary Completion (Actual)

October 22, 2019

Study Completion (Actual)

October 22, 2019

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNTX-4975i-OA-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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