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Vitalis Pharmaceuticals (VTS)-Aspirin and Ketamine for Acute Pain

N/A
Waitlist Available
Led By Sergey Motov, MD
Research Sponsored by Antonios Likourezos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Summary

A combination of ketamine and aspirin for the treatment of acute MSK pain in the ED would confer multimodal analgesia, with the contributions of aspirin and ketamine to an opioid sparing effect. Research on this multimodal approach is sparse, but the minimal empirical evidence supports a clinical benefit to patients in a post orthopedic surgery setting, both in short term and long term. Vitalis Pharmaceuticals (New York, NY) has developed a proprietary formulation of aspirin, VTS-Aspirin, that may deliver faster and stronger pain reduction than traditional aspirin. Preliminary research indicates that combinations of VTS-Aspirin with analgesics may confer greater benefit in pain management than some current standards of care (26). An oral combination drug of VTS-Aspirin and ketamine (VTS-K) would facilitate the shift from IV opioids to a non-IV therapy for patients presenting to the ED with acute MSK pain. This formulation has a potential to provide effective analgesia in the ED with reduced side effects. VTS-K's proprietary oral formulation of established, safe, and well-understood APIs, makes it uniquely appropriate for use in the ED. VTS-K is administered orally, which is suitable for resource-poor environments in which the healthcare setting may be inadequate as well as suitable to improve the throughput of ED Patients by reducing their length of stay. This is especially pertinent given the alternative of IV opioids for pain management of acute MSK pain, which requires both clinical monitoring and equipment, whereas VTS-K promotes weaning off opioids, alleviating the resource consumption.

Eligible Conditions
  • Acute Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The analgesic efficacy of orally administered VTS-K (liquid oral ketamine taken simultaneously with VTS-Aspirin and oral ketamine (in a liquid form)) for pain management of adult ED patients presenting to the ED with acute musculoskeletal pain

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vitalis Pharmaceuticals (VTS)-Aspirin and KetamineExperimental Treatment1 Intervention
An oral combination drug of VTS-Aspirin and ketamine (VTS-K) would facilitate the shift from IV opioids to a non-IV therapy for patients presenting to the ED with acute MSK pain. This formulation has a potential to provide effective analgesia in the ED with reduced side effects. VTS-K's proprietary oral formulation of established, safe, and well-understood APIs, makes it uniquely appropriate for use in the ED. VTS-K is administered orally, which is suitable for resource-poor environments in which the healthcare setting may be inadequate as well as suitable to improve the throughput of ED Patients by reducing their length of stay. This is especially pertinent given the alternative of IV opioids for pain management of acute MSK pain, which requires both clinical monitoring and equipment, whereas VTS-K promotes weaning off opioids, alleviating the resource consumption.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VTS-K
2021
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

Antonios LikourezosLead Sponsor
39 Previous Clinical Trials
8,469 Total Patients Enrolled
3 Trials studying Acute Pain
495 Patients Enrolled for Acute Pain
Sergey Motov, MDPrincipal InvestigatorMaimonides Medical Center
17 Previous Clinical Trials
1,570 Total Patients Enrolled
2 Trials studying Acute Pain
375 Patients Enrolled for Acute Pain
~5 spots leftby Sep 2025