Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
This is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled pivotal study. Approximately 500 adult patients with moderate to severe pain due to OA of the knee will be enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
504
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
0.9% normal saline
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 12
Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 16
Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 20
Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
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Cahaba Research, Inc
Birmingham, Alabama, United States
Affinity Orthopedic Specialists Llc
Birmingham, Alabama, United States
Shoals Medical Trials Inc
Sheffield, Alabama, United States
Gb Family Care
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Clinical Research Institute of Arizona Llc
Surprise, Arizona, United States
Noble Clinical Research Llc
Tucson, Arizona, United States
Biosolutions Clinical Research Center
La Mesa, California, United States
Translational Reseach Group Inc Dba Providence Clinical Research
North Hollywood, California, United States
Prospective Research Innovations Inc
Rancho Cucamonga, California, United States
...and 36 more locations
Time frame: Baseline, Week 24
Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 36
Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 12
PGIC at Week 12 for TLC599 12mg Versus Placebo
Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".
Time frame: Week 12
Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo
Rescue medication use of acetaminophen was provided and recorded in electronic patient diaries. Weekly Total Acetaminophen consumption was tabulated for analysis on a weekly basis, starting from the first date of study drug injection: (Day 1, 8), (Day 8, 15), and so on. Average daily use (e.g., Weekly Total Acetaminophen Consumption divided by 7) was computed to produce Weekly Average Daily Acetaminophen Consumption.
Time frame: through Week 12
Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo
Durable responder endpoints were derived based on the imputed WOMAC pain data. A subject which has ≥ 30% decrease in pain response from Baseline at each visit within a specified time period (x-y). This was derived for patients based on the Injection 1 Baseline for the following time period (x-y): (4-12).
Time frame: Weeks 4 through 12
Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 36
PGIC at Week 36 for TLC599 12mg Versus Placebo
Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".
Time frame: Week 36
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 12
Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Time frame: Baseline, Week 52