Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee Pain
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.
Interventions
OTHERIce Pack and Cooling Device
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
DRUGCNTX-4975-05 (trans-capsaicin)
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).
DRUGCapsaicin
Four intradermal injections of capsaicin, two on each forearm.
Sponsors
Centrexion Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NPRS): Injection-site Pain | Days 1 and 7 | 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
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NPRS): Procedural Pain | Days 1 and 7 | 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): Pain with Walking | Screening through Day 42 | 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. |
| IA Temperature | Days 1 and 7 | Cohorts 1-4: IA temperature measurements. |
| Patient Global Impression of Change (PGIC) | Screening through Day 42 | 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 | Between Days 28 and 35 inclusive; and Day 42 | 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. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Screening through Day 42 | 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. |
Countries
United Kingdom
Outcome results
None listed