This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
1 mg (2mL) IA injection
8% topical patch
15 mL IA injection of 2% lidocaine (without epinephrine)
Well Pharma Medical Research, Corp
Miami, Florida, United States
Capsaicin Pharmacokinetics - AUC0-t
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-t.
Time frame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Capsaicin Pharmacokinetics - AUC0-inf
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-inf.
Time frame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Capsaicin Pharmacokinetics - Cmax
Single-dose systemic exposure to trans- and cis-capsaicin measured by Cmax.
Time frame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment
Change from baseline in KOOS of IA injected knees; 5-point Likert scale: 0 (no problems) to 4 (extreme problems); 5 subscales; each assessed separately
Time frame: Day 1 (pre-dose) or Day 8 (pre-dose) [cross over trial Qutenza® 8% patch or CNTX-4975-05 intra-articular (IA) knee injection], and Week 8 (follow-up)
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Number of participants with TEAEs, which includes laboratory test variables
Time frame: Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)
IA knee Lidocaine Systemic Pharmacokinetics - Concentration
System exposure to lidocaine measured by plasma concentration
Time frame: Day 1 (pre-dose to 3 hours post-dose) or Day 8 (pre-dose to 3 hours post-dose) [Cross over trial Qutenza® 8% patch or CNTX-4975-05 IA knee injection]
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