The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
- Conditions
- Osteoarthritis, Knee
- Interventions
- Registration Number
- NCT03472677
- Lead Sponsor
- Centrexion Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Ice 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). Cohort 2 CNTX-4975-05 (trans-capsaicin) Controlled cooling wrap versus ice pack cooling. Cohort 3 CNTX-4975-05 (trans-capsaicin) Controlled cooling parameters will be determined after evaluation of data from prior cohorts. Cohort 4 CNTX-4975-05 (trans-capsaicin) Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts). Cohort 1 Capsaicin A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine). Cohort 2 Capsaicin Controlled cooling wrap versus ice pack cooling. Cohort 3 Capsaicin Controlled cooling parameters will be determined after evaluation of data from prior cohorts. Cohort 4 Capsaicin Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method IA Temperature Days 1 and 7 Cohorts 1-4: IA temperature measurements.
Numerical Pain Rating Scale (NPRS): Procedural Pain Days 1 and 7 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 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.
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.
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.
Trial Locations
- Locations (1)
MAC Clinical Research
🇬🇧Manchester, United Kingdom