SuspendedPhase 3

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

Stopped: Study activities were suspended due to funding constraints after enrollment completion (N=340). Remaining activities, including data cleaning, database lock, analysis, and reporting, will resume once funding is secured.

United States341 participantsStarted 2022-12-14

Plain-language 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.

Who can participate

Age range18 Years – 64 Years

SexALL

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Inclusion criteria

✓. Written informed consent obtained prior to any study-related procedure being performed.
✓. Male or female subjects between 18 and \<65 years of age at time of consent.
✓. Body weight ≥50 kg.
✓. Physical status rated as ≤2 on the American Society of Anesthesiologists (ASA) rating scale (Owens, Felts et al. 1978).
✓. Scheduled to undergo primary unilateral first metatarsal bunionectomy.
✓. Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry, throughout the study, and for 7 days after the last dose of study drug (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a negative urine pregnancy test before surgery.
✓. Subject is willing and able to complete all study procedures including training on pain scales, follow instructions, communicate meaningfully with study personnel, and return for all visits as listed in the protocol.

Exclusion criteria

What they're measuring

Summed Pain Intensity Difference (SPID24)

Timeframe: 0 to 24 hours after start of administration

Trial details

NCT IDNCT05324358

SponsorNeumentum, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-06

View on ClinicalTrials.gov More Pain, Postoperative trials