drugset
drugset / Trial / NCT05324358

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

NCT05324358 ↗

Phase 3 Suspended 341 enrolled Neumentum, Inc. NEMA Research, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-12-14
Primary completion
2024-09-06
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Tromethamine Small molecule 3.5 mg Intravenous
Comparator Morphine Other / unclassified 4 mg Intravenous

Indications

No indication recorded.