BunionPhase 3NCT05831449
CPL-01 in the Management of Postoperative Pain After Bunionectomy
A Phase 3 study testing Local anesthetic injection of CPL-01, Naropin, 0.5% Injectable Solution and Morphine rescue medication in people with Bunion and Post-operative Pain, run by Cali Pharmaceuticals LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bunion, Post-operative Pain
- What is being tested?
- Local anesthetic injection of CPL-01, Naropin, 0.5% Injectable Solution and Morphine rescue medication
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 616 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 6 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to sign ICF
- Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
- BMI ≤ 39 kg/m2
- If biologically female, not pregnant or planning to become pregnant over the study
- If biologically male, either sterile or using acceptable form of birth control
- Be willing and able to complete study procedures
Who cannot join
- Has previously undergone unilateral simple bunionectomy.
- Has a planned concurrent surgical procedure
- Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments
- Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments.
- Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
- Has history or evidence of impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
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- Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN).
- Has a history of malignancy in the past year
- Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy
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.
Read the detailed description
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.
- Conditions
- Bunion, Post-operative Pain
- Being tested
- Local anesthetic injection of CPL-01, Naropin, 0.5% Injectable Solution, Placebo, Morphine rescue medication, Acetaminophen rescue medication
- Medical subject headings
- Bunion, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic injection of CPL-01Drug
Also called CPL-01, Long-acting ropivacaine
Local anesthetic injection (CPL-01)
Naropin, 0.5% Injectable SolutionDrug
Also called ropivacaine HCl
Local anesthetic injection (positive control [Naropin])
PlaceboDrug
Also called Saline placebo
Local anesthetic injection (negative control [saline placebo])
Morphine rescue medicationDrug
Also called Opioids (intravenous [IV] morphine)
Rescue opioid (IV morphine) allowed if requested
Acetaminophen rescue medicationDrug
Also called Non-opioid oral acetaminophen
Rescue non-opioid (oral acetaminophen) allowed if requested
Oxycodone rescue medicationDrug
Also called Opioids (oral [PO] oxycodone)
Rescue opioid (PO oxycodone) allowed if requested
BunionectomyProcedure or surgery
Also called Bunion repair
Operative bunion repair
| Study group | Role | What they receive |
|---|---|---|
| CPL-01 | Experimental | Local infiltration of study drug Receives: Drug: Local anesthetic injection of CPL-01; Drug: Morphine rescue medication; Drug: Acetaminophen rescue medication; Drug: Oxycodone rescue medication; Procedure: Bunionectomy |
| Ropivacaine HCl | Active comparator | Local infiltration of study drug Receives: Drug: Naropin, 0.5% Injectable Solution; Drug: Morphine rescue medication; Drug: Acetaminophen rescue medication; Drug: Oxycodone rescue medication; Procedure: Bunionectomy |
| Placebo | Placebo comparator | Local infiltration of study drug Receives: Drug: Placebo; Drug: Morphine rescue medication; Drug: Acetaminophen rescue medication; Drug: Oxycodone rescue medication; Procedure: Bunionectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start22 May 2023
- Primary completion25 Sep 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BunionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cali Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Onel, Study director, Cali Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831449
- Sponsor's protocol ID
- CPL-01-302
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy
- ClinicalTrials.gov ID
- NCT05831449
- Acronym / sponsor ID
- CPL-01-302
- Conditions
- Bunion, Post-operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- Cali Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPL-01 | Experimental | Drug: Local anesthetic injection of CPL-01, Drug: Morphine rescue medication, Drug: Acetaminophen rescue medication, Drug: Oxycodone rescue medication, Procedure: BunionectomyLocal infiltration of study drug |
| Ropivacaine HCl | Active comparator | Drug: Naropin, 0.5% Injectable Solution, Drug: Morphine rescue medication, Drug: Acetaminophen rescue medication, Drug: Oxycodone rescue medication, Procedure: BunionectomyLocal infiltration of study drug |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Morphine rescue medication, Drug: Acetaminophen rescue medication, Drug: Oxycodone rescue medication, Procedure: BunionectomyLocal infiltration of study drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to sign ICF
- Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
- BMI ≤ 39 kg/m2
- If biologically female, not pregnant or planning to become pregnant over the study
- If biologically male, either sterile or using acceptable form of birth control
Key exclusion criteria (9 listed)
- Has previously undergone unilateral simple bunionectomy.
- Has a planned concurrent surgical procedure
- Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments
- Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments.
- Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anesthetic injection of CPL-01Also: CPL-01, Long-acting ropivacaineLocal anesthetic injection (CPL-01) | Drug | CPL-01 |
| Naropin, 0.5% Injectable SolutionAlso: ropivacaine HClLocal anesthetic injection (positive control [Naropin]) | Drug | Ropivacaine HCl |
| PlaceboAlso: Saline placeboLocal anesthetic injection (negative control [saline placebo]) | Drug | Placebo |
| Morphine rescue medicationAlso: Opioids (intravenous [IV] morphine)Rescue opioid (IV morphine) allowed if requested | Drug | CPL-01, Placebo, Ropivacaine HCl |
| Acetaminophen rescue medicationAlso: Non-opioid oral acetaminophenRescue non-opioid (oral acetaminophen) allowed if requested | Drug | CPL-01, Placebo, Ropivacaine HCl |
| Oxycodone rescue medicationAlso: Opioids (oral [PO] oxycodone)Rescue opioid (PO oxycodone) allowed if requested | Drug | CPL-01, Placebo, Ropivacaine HCl |
| BunionectomyAlso: Bunion repairOperative bunion repair | Procedure or surgery | CPL-01, Placebo, Ropivacaine HCl |
Primary outcome
Cumulative Pain Score
Time frame: 72 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erol Onel study director
Cali Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Local anesthetic injection of CPL-01, Naropin, 0.5% Injectable Solution and Morphine rescue medication in people with Bunion and Post-operative Pain, run by Cali Pharmaceuticals LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Pain Score (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.