A Phase 3 interventional study of Local anesthetic injection of CPL-01 and Naropin, 0.5% Injectable Solution in Bunion and Post-operative Pain, sponsored by Cali Pharmaceuticals LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Cali Pharmaceuticals LLC · Phase 3, Interventional, and Treatment
Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.
After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. Subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. Follow-up will then occur at 7 and 30 days afterwards.
The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms.
58 studies on the registry are indexed under Bunion; 5 are open to participants now.
This study's enrollment of 616 is above the median of 100 across 47 interventional studies indexed under Bunion.
Browse Bunion studies →Cali Pharmaceuticals LLC is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Local infiltration of study drug
Drug: Local anesthetic injection of CPL-01 · Drug: Morphine rescue medication · Drug: Acetaminophen rescue medication · Drug: Oxycodone rescue medication · Procedure: Bunionectomy
Local infiltration of study drug
Drug: Naropin, 0.5% Injectable Solution · Drug: Morphine rescue medication · Drug: Acetaminophen rescue medication · Drug: Oxycodone rescue medication · Procedure: Bunionectomy
Local infiltration of study drug
Drug: Placebo · Drug: Morphine rescue medication · Drug: Acetaminophen rescue medication · Drug: Oxycodone rescue medication · Procedure: Bunionectomy
Local anesthetic injection (CPL-01)
Also known as: CPL-01, Long-acting ropivacaine
Local anesthetic injection (positive control \[Naropin\])
Also known as: ropivacaine HCl
Local anesthetic injection (negative control \[saline placebo\])
Also known as: Saline placebo
Rescue opioid (IV morphine) allowed if requested
Also known as: Opioids (intravenous [IV] morphine)
Rescue non-opioid (oral acetaminophen) allowed if requested
Also known as: Non-opioid oral acetaminophen
Rescue opioid (PO oxycodone) allowed if requested
Also known as: Opioids (oral [PO] oxycodone)
Operative bunion repair
Also known as: Bunion repair
Cumulative Pain Score
Area Under the Curve of the Numeric Rating Scale Score for Pain with Activity. Activity is resting the operative foot with the ball on the floor. Pain Score spans from 0 to 10, where 0 is no pain and 10 is worst pain imaginable.
Time frame: 72 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in Sep 2025, 28 months.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CPL-01
Cali Pharmaceuticals LLC