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Analgesic

Analgesic Non Narcotic for Bunions (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
Awards & highlights

MERIT-2 Trial Summary

This trial is testing a new pain medication for people who are having surgery to correct a bunion. The trial has two parts: first, different doses of the medication are tested to see what works best; then, the best dose is tested again in a larger group of people.

Eligible Conditions
  • Bunion

MERIT-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC72
Secondary outcome measures
Opioid use (MME)

MERIT-2 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any vacancies for individuals wishing to participate in this research?

"Indeed, data published on clinicaltrials.gov verifies that this research project is presently recruiting participants. The trial was first made public on June 14th 2022 and has seen its most recent update as of July 18th 2022."

Answered by AI

What criteria do participants need to meet in order to qualify for this research endeavor?

"This clinical trial is accepting 230 pain-stricken individuals between the ages of 18 and 75. It should be noted that potential participants have to meet certain requirements in order to qualify, such as having a Body Mass Index (BMI) below 39 kg/m2, being classified as ASA Class I or II at randomization, and consenting to sign an Informed Consent Form before taking part. Furthermore, they must plan on undergoing elective primary unilateral distal first metatarsal bunionectomy with osteotomy and internal fixation under regional anaesthesia without additional procedures or surgeries."

Answered by AI

Is senior participation being taken into consideration for this experiment?

"This clinical trial mandates that participants must be at least 18 years of age and not exceed 75."

Answered by AI

What potential risks do Analgesic Non Narcotic medications pose to individuals?

"Our assessment of Analgesic Non Narcotic's safety resulted in a rating of 2 on our scale, since the Phase 2 trial has generated some data regarding its security but none concerning its efficacy."

Answered by AI

How many participants are partaking in this clinical experiment?

"The sponsor, Cali Pharmaceuticals LLC, must recruit a total of 230 eligible patients from various sites, such as Jean Brown Research in Salt Lake City and Arizona Research Center in Phoenix."

Answered by AI

Who else is applying?

What site did they apply to?
Jean Brown Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have to have this bonuion removed in pain.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
2022. "Post-Operative Pain and Opioid Reduction Trial After Bunionectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05411861.
~26 spots leftby Apr 2025
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