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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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 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).
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.
MAC Clinical Research
Manchester, United Kingdom
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.
Time frame: Days 1 and 7
IA Temperature
Cohorts 1-4: IA temperature measurements.
Time frame: Days 1 and 7
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.
Time frame: Days 1 and 7
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.
Time frame: Days 1 and 7
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.
Time frame: Screening through Day 42
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.
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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.
Four intradermal injections of capsaicin, two on each forearm.
Time frame: Screening through Day 42
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.
Time frame: Screening through Day 42
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.
Time frame: Between Days 28 and 35 inclusive; and Day 42