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A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CNTX-4975-05
Placebo
Sponsored by
Centrexion Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring analgesic, non-opioid, capsaicin, intra-articular, osteoarthritis, pain, knee pain

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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.

Sites / Locations

  • Alabama Orthopaedic Center - Research
  • Cahaba Research, Inc
  • Coastal Clinical Research, Inc
  • Noble Clinical Research, LLC
  • Orange County Research Institute
  • Core Healthcare Group
  • Biosolutions Clinical Research Center
  • Providence Clinical Research
  • Medical Associates Research Group
  • Encompass Clinical Research
  • Tampa Bay Medical Research, Inc
  • Avail Clinical Research, LLC
  • M&M Medical Center, Inc
  • Sensible Healthcare, LLC
  • Jewett Orthopaedic
  • Clinical Research of West Florida, Inc.
  • Drug Studies America
  • Georgia Institute for Clinical Research, LLC
  • Atlanta Orthopaedic Institute, LLC
  • MediSphere Medical Research Center, LLC
  • Mid America PolyClinic
  • Tufts Medical Center
  • Tristan Medical Enterprises PC, dba
  • Medical Research Associates, Inc
  • Sundance Clinical Research, LLC
  • Clinical Research Consortium
  • Hassman Research Institute
  • Bone Joint & Spine Surgeons, Inc
  • Tekton Research, Inc
  • Metroplex Clinical Research Center
  • Clinical Investigations of Texas
  • Ortho Virginia
  • Charlottesville Medical Research Center, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

CNTX-4975-05

Arm Description

Matching placebo of 2.0 mL for IA injection

Pre-filled glass syringes administered as a single 2.0 mL IA injection

Outcomes

Primary Outcome Measures

Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
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

Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score
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 WOMAC B (Stiffness) Dimension Total Score
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 C (Physical Function) Dimension Total Score
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.

Full Information

First Posted
January 31, 2018
Last Updated
July 18, 2022
Sponsor
Centrexion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03429049
Brief Title
A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
Official Title
A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centrexion Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
analgesic, non-opioid, capsaicin, intra-articular, osteoarthritis, pain, knee pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo of 2.0 mL for IA injection
Arm Title
CNTX-4975-05
Arm Type
Experimental
Arm Description
Pre-filled glass syringes administered as a single 2.0 mL IA injection
Intervention Type
Drug
Intervention Name(s)
CNTX-4975-05
Intervention Description
Receiving CNTX-4975-05 injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Receiving Placebo injection
Primary Outcome Measure Information:
Title
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score
Description
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.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score
Description
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.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score
Description
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.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall M. Stevens, MD
Organizational Affiliation
Centrexion Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Orthopaedic Center - Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Cahaba Research, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Coastal Clinical Research, Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Noble Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Orange County Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Biosolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Tampa Bay Medical Research, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
M&M Medical Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Jewett Orthopaedic
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Institute for Clinical Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Atlanta Orthopaedic Institute, LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Mid America PolyClinic
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Tristan Medical Enterprises PC, dba
City
North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
Facility Name
Medical Research Associates, Inc
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49686
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Bone Joint & Spine Surgeons, Inc
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Tekton Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Clinical Investigations of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Ortho Virginia
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States

12. IPD Sharing Statement

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A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

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