This clinical study is a randomized, double-blind, double-dummy, parallel group, multi-center, active and placebo-controlled trial evaluating the analgesic efficacy and safety of NTM-001 in subjects with moderately severe postoperative pain after bunionectomy surgery. This study is designed to compare the efficacy of NTM-001 to placebo. Intravenous (IV) morphine serves as an active comparator to determine assay sensitivity and support assessment of opioid-level analgesia for NTM-001. Effectiveness, safety, and tolerability parameters will be descriptively compared between treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
341
Ketorolac tromethamine, alcohol free formulation, 1.0 mg/mL in saline solution (\~0.9% NaCl) adjusted to a pH of \~7.4. Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL of NTM-001).
Morphine single use vials at 4 mg/mL, filled with 1 mL.
Placebo alcohol free saline solution (\~0.9% NaCl; matching active NTM-001). Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL Placebo solution).
Placebo single use vials with saline (matching active morphine).
Sun City Clinical Research
Sun City, Arizona, United States
Trovare Clinical Research
Bakersfield, California, United States
Alliance Research Intitute
Canoga Park, California, United States
Pasadena Clinical Trials
Pomona, California, United States
Dr. Vince Clinical Research
Overland Park, Kansas, United States
Chesapeake Research
Pasadena, Maryland, United States
Curalta Clinical Trials
Westwood, New Jersey, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
The Orthopedic Center
Tulsa, Oklahoma, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Summed Pain Intensity Difference (SPID24)
The primary endpoint is the Summed Pain Intensity Difference over 24h (SPID24) from start to end of administration of investigational medicinal product (IMP). Calculated as the weighted sum of the PID (difference between baseline at qualifying period and current pain intensity) collected at protocol scheduled time points through up to 24h after starting infusion of the IMP, using the following formula: SPID24 = Σ Wi \* PIDi (1) where the Σ sums over all observations collected from the first assessment after the first IMP administration to Hour 24 and Wi is the time elapsed from the previous observation PIDi-1 to the current observation PIDi.
Time frame: 0 to 24 hours after start of administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.