Hallux Valgus and BunionPhase 2MERIT-2NCT05411861
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
A Phase 2 study testing Analgesic Non Narcotic in people with Hallux Valgus and Bunion, run by Cali Pharmaceuticals LLC at 3 sites in United States.
Trial summary
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hallux Valgus and Bunion
- What is being tested?
- Analgesic Non Narcotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jun 2022to 7 Nov 2022
- Phase
- Phase 2
- 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
- Be willing and able to sign the informed consent form (ICF) prior to study participation
- In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization
- Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
- Have a BMI ≤ 39 kg/m2
Who cannot join
- Previous unilateral simple bunionectomy
- Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol
- Concurrent painful condition
- Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery
- Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study
- History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments
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- History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency
- History or evidence of impaired liver function (e.g., ALT > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis
- History or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN)
- History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix
- Has or has had active COVID-19 infection within 3 months prior to surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Trovare Clinical Research
Bakersfield, California, 93301
Arizona Research Center
Phoenix, Arizona, 85053
Jean Brown Research
Salt Lake City, Utah, 84107
About this study
Official title: Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate Safety, Efficacy, and PK of CPL-01 in Post-Op Pain After Unilateral Distal First Metatarsal Bunionectomy + Osteotomy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
Read the detailed description
Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit.
- Conditions
- Hallux Valgus and Bunion
- Being tested
- Analgesic Non Narcotic
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic Non NarcoticDrug
Also called Infiltration of local analgesic
Injection of protocol-specified volume of local analgesic
| Study group | Role | What they receive |
|---|---|---|
| CPL-01 | Experimental | Low dose of CPL-01 Receives: Drug: Analgesic Non Narcotic |
| Ropivacaine HCl | Active comparator | Low dose of Ropivacaine HCl Receives: Drug: Analgesic Non Narcotic |
| Placebo | Placebo comparator | Low volume of placebo Receives: Drug: Analgesic Non Narcotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC72
Pain score through 72 hours post-operative
Measured: 72 hours post-operative
Secondary outcomes (1)
Opioid use (MME)
Opioid use through 72 hours post-operative
Measured: 72 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start14 Jun 2022
- Primary completion26 Sep 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus and 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Bunion Surgery
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cali Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erol Onel, Study chair, Cali Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411861
- Sponsor's protocol ID
- CPL-01-202
- Acronym
- MERIT-2
- Status last verified
- Jan 2023
- First submitted
- 7 Jun 2022
- Last updated
- 11 Jan 2023
- 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate Safety, Efficacy, and PK of CPL-01 in Post-Op Pain After Unilateral Distal First Metatarsal Bunionectomy + Osteotomy
- ClinicalTrials.gov ID
- NCT05411861
- Acronym / sponsor ID
- MERIT-2 / CPL-01-202
- Conditions
- Hallux Valgus and Bunion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cali Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 9 Jun 2022 (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.
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
Detailed description
Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Bunion Surgery
| Arm | Type | Receives |
|---|---|---|
| CPL-01 | Experimental | Drug: Analgesic Non NarcoticLow dose of CPL-01 |
| Ropivacaine HCl | Active comparator | Drug: Analgesic Non NarcoticLow dose of Ropivacaine HCl |
| Placebo | Placebo comparator | Drug: Analgesic Non NarcoticLow volume of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be willing and able to sign the informed consent form (ICF) prior to study participation
- In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization
- Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
- Have a BMI ≤ 39 kg/m2
Key exclusion criteria (11 listed)
- Previous unilateral simple bunionectomy
- Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol
- Concurrent painful condition
- Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery
- Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study
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 |
|---|---|---|
| Analgesic Non NarcoticAlso: Infiltration of local analgesicInjection of protocol-specified volume of local analgesic | Drug | CPL-01, Placebo, Ropivacaine HCl |
Primary outcome
AUC72
Time frame: 72 hours post-operative
Pain score through 72 hours post-operative
1 secondary outcome
Opioid use (MME)
Time frame: 72 hours post-operative
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 11 Jan 2023.
- 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 chair
Cali Biosciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Analgesic Non Narcotic in people with Hallux Valgus and Bunion, run by Cali Pharmaceuticals LLC at 3 sites 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 4 inclusion and 11 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
AUC72 (time frame: 72 hours post-operative). 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 11 Jan 2023.