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Analgesic

Post-Operative Pain and Opioid Reduction Trial After Bunionectomy (MERIT-2 Trial)

Phase 2
Waitlist Available
Research Sponsored by Cali Pharmaceuticals LLC
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 72 hours post-operative

Summary

This trial tests a new pain relief drug (CPL-01) in patients having bunion surgery. The drug is injected at the end of surgery to help manage pain. Patients will stay in the hospital for a few days for monitoring and return for follow-up visits. The new drug has shown superior pain relief in bunionectomy patients compared to standard care.

Eligible Conditions
  • Bunion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC72
Secondary study objectives
Opioid use (MME)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CPL-01Experimental Treatment1 Intervention
Low dose of CPL-01
Group II: Ropivacaine HClActive Control1 Intervention
Low dose of Ropivacaine HCl
Group III: PlaceboPlacebo Group1 Intervention
Low volume of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Analgesic Non Narcotic
2022
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Cali Pharmaceuticals LLCLead Sponsor
4 Previous Clinical Trials
1,203 Total Patients Enrolled
Erol OnelStudy ChairCali Biosciences
2 Previous Clinical Trials
1,078 Total Patients Enrolled
~21 spots leftby Dec 2025
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