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SUSPENDED
NCT05324358
PHASE3

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy

Sponsor: Neumentum, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Active and Placebo-Controlled Trial to Evaluate the Analgesic Efficacy and Safety of NTM-001 for the Treatment of Moderately Severe Postoperative Pain Following Bunionectomy

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

341

Start Date

2022-12-14

Completion Date

2027-05

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

DRUG

Ketorolac Tromethamine

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).

DRUG

Morphine Sulfate

Morphine single use vials at 4 mg/mL, filled with 1 mL.

OTHER

Intravenous Placebo for NTM-001

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).

OTHER

IV Placebo for Morphine

Placebo single use vials with saline (matching active morphine).

Locations (10)

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