Back to resultsThe Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Ice Pack and Cooling Device
CNTX-4975-05 (trans-capsaicin)
CNTX-4975-05 (trans-capsaicin)
CNTX-4975-05 (trans-capsaicin)
Capsaicin
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee Pain
Eligibility Criteria
Cohort 1 Key Inclusion Criteria:
- Subject is aged between 18 and 45 years, inclusive.
- Subjects Body Mass Index (BMI) is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
- Subjects must be in good health, in the opinion of the Investigator, as determined by a medical history, physical examination, clinical laboratory tests, vital signs and 12 lead electrocardiogram (ECG).
Cohort 1 Key Exclusion Criteria:
- Subject has had a clinically significant illness that has not completely resolved in the four weeks before screening.
- Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
Cohorts 2-4 Key Inclusion Criteria:
- Subject is aged between 45 and 75 years, inclusive.
- Subject's BMI is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
- Subject has a diagnosis of bilateral moderate to severe painful knee OA (subjects will be required to have a score on Pain with walking in the previous 24 hours, of 4 to 9, inclusive NPRS 0-10). The condition must be chronic with a history of painful arthritis for at least 3 months prior to entry in the study.
Cohorts 2-4 Key Exclusion Criteria:
- Subject has had a clinically significant illness, other than osteoarthritis, that has not completely resolved in the four weeks before screening.
- Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
- Subject has used analgesic medications in the 2 days prior to dosing, except for paracetamol, as needed.
- Subject has used topical medications applied to the knee for OA pain (including capsaicin, lidocaine, prescription or OTC medications) from 90 days prior to screening through to dosing.
- Subject has been injected with corticosteroids in the knee 90 days prior to screening through to dosing.
- Subject currently uses opioids for any condition other than OA knee pain (maximum dose 15 mg hydrocodone, or equivalent, per day prescribed by a physician).
Sites / Locations
- MAC Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Arm Description
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
Controlled cooling wrap versus ice pack cooling.
Controlled cooling parameters will be determined after evaluation of data from prior cohorts.
Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).
Outcomes
Primary Outcome Measures
Numerical Pain Rating Scale (NPRS): Injection-site Pain
Cohorts 2-4: Change in injection-site pain following intra-articular (IA) administration of CNTX-4975-05 (trans-capsaicin) scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Secondary Outcome Measures
IA Temperature
Cohorts 1-4: IA temperature measurements.
Numerical Pain Rating Scale (NPRS): Procedural Pain
Cohort 1: Procedural pain following single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine) using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Numerical Pain Rating Scale (NPRS): Procedural Pain
Cohorts 2-4: Procedural pain following intradermal (ID) administration of the challenge agent capsaicin as a function of temperature scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Numerical Pain Rating Scale (NPRS): Pain with Walking
Cohorts 2-4: Average pain with walking over the past 24 hours scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Cohorts 2-4: Calculation of KOOS for each painful osteoarthritis knee on a scale of 0 to 100 with 0 representing extreme problems and 100 representing no problems.
Patient Global Impression of Change (PGIC)
Cohorts 2-4: Change in knee pain for each painful osteoarthritis knee scored using PGIC on a scale of 1 to 7 with 1 representing very much improved and 7 representing very much worse.
Numerical Pain Rating Scale (NPRS): Thermal Pain
Cohorts 1-4: Thermal pain approximately two weeks following intradermal (ID) administration of the challenge agent capsaicin scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Full Information
NCT ID
NCT03472677
First Posted
March 4, 2018
Last Updated
December 14, 2018
Sponsor
Centrexion Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT03472677
Brief Title
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
Official Title
A Phase 1b Study to Characterize the Effect of Injection Site Cooling on Pain Experienced After CNTX-4975-05 (Trans-capsaicin) Intra-articular and Capsaicin Intradermal Injections in Healthy Volunteers and Subjects With Bilateral Painful Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
August 3, 2018 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Controlled cooling wrap versus ice pack cooling.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Controlled cooling parameters will be determined after evaluation of data from prior cohorts.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).
Intervention Type
Other
Intervention Name(s)
Ice Pack and Cooling Device
Intervention Description
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
Intervention Type
Drug
Intervention Name(s)
CNTX-4975-05 (trans-capsaicin)
Intervention Description
Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).
Intervention Type
Drug
Intervention Name(s)
CNTX-4975-05 (trans-capsaicin)
Intervention Description
Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Intervention Type
Drug
Intervention Name(s)
CNTX-4975-05 (trans-capsaicin)
Intervention Description
Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Intervention Description
Four intradermal injections of capsaicin, two on each forearm.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS): Injection-site Pain
Description
Cohorts 2-4: Change in injection-site pain following intra-articular (IA) administration of CNTX-4975-05 (trans-capsaicin) scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Time Frame
Days 1 and 7
Secondary Outcome Measure Information:
Title
IA Temperature
Description
Cohorts 1-4: IA temperature measurements.
Time Frame
Days 1 and 7
Title
Numerical Pain Rating Scale (NPRS): Procedural Pain
Description
Cohort 1: Procedural pain following single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine) using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Time Frame
Days 1 and 7
Title
Numerical Pain Rating Scale (NPRS): Procedural Pain
Description
Cohorts 2-4: Procedural pain following intradermal (ID) administration of the challenge agent capsaicin as a function of temperature scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Time Frame
Days 1 and 7
Title
Numerical Pain Rating Scale (NPRS): Pain with Walking
Description
Cohorts 2-4: Average pain with walking over the past 24 hours scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Time Frame
Screening through Day 42
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Cohorts 2-4: Calculation of KOOS for each painful osteoarthritis knee on a scale of 0 to 100 with 0 representing extreme problems and 100 representing no problems.
Time Frame
Screening through Day 42
Title
Patient Global Impression of Change (PGIC)
Description
Cohorts 2-4: Change in knee pain for each painful osteoarthritis knee scored using PGIC on a scale of 1 to 7 with 1 representing very much improved and 7 representing very much worse.
Time Frame
Screening through Day 42
Title
Numerical Pain Rating Scale (NPRS): Thermal Pain
Description
Cohorts 1-4: Thermal pain approximately two weeks following intradermal (ID) administration of the challenge agent capsaicin scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Time Frame
Between Days 28 and 35 inclusive; and Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Cohort 1 Key Inclusion Criteria:
Subject is aged between 18 and 45 years, inclusive.
Subjects Body Mass Index (BMI) is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
Subjects must be in good health, in the opinion of the Investigator, as determined by a medical history, physical examination, clinical laboratory tests, vital signs and 12 lead electrocardiogram (ECG).
Cohort 1 Key Exclusion Criteria:
Subject has had a clinically significant illness that has not completely resolved in the four weeks before screening.
Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
Cohorts 2-4 Key Inclusion Criteria:
Subject is aged between 45 and 75 years, inclusive.
Subject's BMI is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
Subject has a diagnosis of bilateral moderate to severe painful knee OA (subjects will be required to have a score on Pain with walking in the previous 24 hours, of 4 to 9, inclusive NPRS 0-10). The condition must be chronic with a history of painful arthritis for at least 3 months prior to entry in the study.
Cohorts 2-4 Key Exclusion Criteria:
Subject has had a clinically significant illness, other than osteoarthritis, that has not completely resolved in the four weeks before screening.
Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
Subject has used analgesic medications in the 2 days prior to dosing, except for paracetamol, as needed.
Subject has used topical medications applied to the knee for OA pain (including capsaicin, lidocaine, prescription or OTC medications) from 90 days prior to screening through to dosing.
Subject has been injected with corticosteroids in the knee 90 days prior to screening through to dosing.
Subject currently uses opioids for any condition other than OA knee pain (maximum dose 15 mg hydrocodone, or equivalent, per day prescribed by a physician).
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
MAC Clinical Research
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
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