Postoperative PainPhase 3NCT07490496
Phase 3 Bunionectomy Study
A Phase 3 study testing CPL-01 in people with Postoperative Pain and Bunion, run by Cali Pharmaceuticals LLC at 1 site in United States.
Trial summary
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Bunion
- What is being tested?
- CPL-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 30 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Bunion
Who cannot join
- Concomitant conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
CenExel
Salt Lake City, Utah, 84107
Todd Bertoch, MD, 801-261-2000, e.onel@calibiosciences.com
About this study
Official title: A Randomized, Double-Blind, Placebo-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
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
Read the detailed description
After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.
- Conditions
- Postoperative Pain, Bunion
- Being tested
- CPL-01, saline placebo
- Keywords
- bunionectomy, bunion, osteotomy
- Medical subject headings
- Pain, Postoperative, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL-01Drug
Administration by the Surgeon during the operation
saline placeboDrug
Administration by the Surgeon during the operation
| Study group | Role | What they receive |
|---|---|---|
| CPL-01 | Experimental | Intra-operative local administration Receives: Drug: CPL-01 |
| Saline placebo | Placebo comparator | Intra-operative local administration Receives: Drug: saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain with activity
AUC NRS-A wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain with Activity where 0 is no pain and 10 is worst pain imaginable)
Measured: 24 hours
Secondary outcomes (2)
Postoperative Pain with rest
AUC NRS-R wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain at Rest where 0 is no pain and 10 is worst pain imaginable)
Measured: 24 hours, 72 hours
Postoperative rescue medication use
Opioid and non-opioid pain control medicines needed
Measured: 24 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Model description
- Bunionectomy
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cali Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Bertoch, MD, Principal investigator, CenExel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490496
- Sponsor's protocol ID
- CPL-01-3021
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD necessary for results
Publications
Xu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. Efficacy, safety, and pharmacokinetics of CPL-01, an investigational long-acting ropivacaine, in bunionectomy: Results of a phase 2b study. J Foot Ankle Surg. 2025 Mar-Apr;64(2):150-156. doi: 10.1053/j.jfas.2024.09.007. Epub 2024 Sep 19.
PubMed 39303759
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-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
- NCT07490496
- Acronym / sponsor ID
- CPL-01-3021
- Conditions
- Postoperative Pain, Bunion
- Keywords
- bunionectomy, bunion, osteotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Cali Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 24 Mar 2026 (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.
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
Detailed description
After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Bunionectomy
| Arm | Type | Receives |
|---|---|---|
| CPL-01 | Experimental | Drug: CPL-01Intra-operative local administration |
| Saline placebo | Placebo comparator | Drug: saline placeboIntra-operative local administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bunion
Key exclusion criteria (1 listed)
- Concomitant conditions
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 |
|---|---|---|
| CPL-01Administration by the Surgeon during the operation | Drug | CPL-01 |
| saline placeboAdministration by the Surgeon during the operation | Drug | Saline placebo |
Primary outcome
Postoperative Pain with activity
Time frame: 24 hours
AUC NRS-A wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain with Activity where 0 is no pain and 10 is worst pain imaginable)
2 secondary outcomes
Postoperative Pain with rest
Time frame: 24 hours, 72 hours
Postoperative rescue medication use
Time frame: 24 hours, 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 39303759Xu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. Efficacy, safety, and pharmacokinetics of CPL-01, an investigational long-acting ropivacaine, in bunionectomy: Results of a phase 2b study. J Foot Ankle Surg. 2025 Mar-Apr;64(2):150-156. doi: 10.1053/j.jfas.2024.09.007. Epub 2024 Sep 19.
- Individual participant dataSharing planned: Yes. All IPD necessary for results
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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.
Todd Bertoch, MD principal investigator
CenExel
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 CPL-01 in people with Postoperative Pain and Bunion, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 21 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erol Onel, MD (203-837-6500, e.onel@calibiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain with activity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07490496, which also lists 1 linked publication.
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 21 Oct 2026.