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NMDA Receptor Antagonist
A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain
Phase 4
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 60 minutes
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
Acute Pain is one of the most frequent chief complaints and the main reason for visiting the Emergency Department (ED). The acute pain in the ED is largely prevalent across the country with recent literature demonstrating that 61-91% of patients are admitted to the ED due to a variety of acute painful syndromes. There is a lack of good options for pain control in such settings.
Eligible Conditions
- Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain Score at 60 Minutes
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Group I: OK GroupActive Control1 Intervention
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine
Group II: AOK GroupActive Control1 Intervention
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
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Who is running the clinical trial?
Antonios LikourezosLead Sponsor
40 Previous Clinical Trials
8,574 Total Patients Enrolled
17 Trials studying Pain
1,161 Patients Enrolled for Pain
Sergey Motov, MDPrincipal InvestigatorMaimonides Medical Center
18 Previous Clinical Trials
1,715 Total Patients Enrolled
10 Trials studying Pain
885 Patients Enrolled for Pain
Leily Naraghi Bagher Pour, MDPrincipal InvestigatorMaimonides Medical Center