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Local Anesthetic
CPL-01 for Postoperative Pain
Phase 3
Recruiting
Research Sponsored by Cali Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If biologically male, either sterile or using acceptable form of birth control
If biologically female, not pregnant or planning to become pregnant over the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
Study Summary
This trial tests if a drug can reduce pain & opioid use after bunionectomy, compared to other treatments.
Who is the study for?
This trial is for adults with bunions requiring surgery who can consent to the study. They must have a BMI ≤ 39, not be pregnant or planning pregnancy, and if male, use birth control. Excluded are those with other painful conditions, significant health issues that could affect participation, liver or kidney impairments, recent cancer history, past bunionectomy or daily opioid use within six months.Check my eligibility
What is being tested?
The trial tests CPL-01's effectiveness in managing postoperative pain after bunion surgery compared to Naropin and placebo. The goal is to see if CPL-01 reduces pain and opioid consumption more effectively than the controls following surgery.See study design
What are the potential side effects?
Potential side effects may include typical reactions to local anesthetics such as numbness beyond the target area, allergic reactions, nausea or vomiting. Specific side effects of CPL-01 aren't detailed but would likely align with common local anesthetic risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man who is either sterile or using reliable birth control.
Select...
I am not pregnant nor planning to become pregnant during the study.
Select...
I am scheduled for a specific bunion surgery on one foot without any additional procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative Pain Score
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CPL-01Experimental Treatment1 Intervention
Local infiltration of study drug
Group II: Ropivacaine HClActive Control1 Intervention
Local infiltration of study drug
Group III: PlaceboPlacebo Group1 Intervention
Local infiltration of study drug
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Who is running the clinical trial?
Cali Pharmaceuticals LLCLead Sponsor
4 Previous Clinical Trials
702 Total Patients Enrolled
Erol OnelStudy DirectorCali Biosciences
2 Previous Clinical Trials
577 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a painful condition that might affect pain assessments in the study.I am willing and able to follow the study's procedures.I am a man who is either sterile or using reliable birth control.I do not have any major health or mental issues that could affect my participation in the study.I have a history of malignant hyperthermia or G6PD deficiency.I am not pregnant nor planning to become pregnant during the study.My kidney function is impaired.My liver isn't working properly, with high enzyme levels or I have liver disease.I am scheduled for a specific bunion surgery on one foot without any additional procedures.I can sign the informed consent form.Your body mass index (BMI) is less than or equal to 39.I am scheduled for surgery soon.I have had cancer in the last year.I have had surgery to remove a bunion on one foot.I have used opioids daily for a week or more in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: CPL-01
- Group 2: Ropivacaine HCl
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it permissible for me to become involved in this investigation?
"This medical trial requires that applicants have bunions, be between 18 and 75 years of age, and is seeking to recruit a total 574 participants."
Answered by AI
Does the medical study accept minors as participants?
"To be accepted for this medical trial, participants must fall between the ages of 18 and 75. There is a separate category of 66 trials available to individuals under 18 years old, as well as 402 more suitable for those over 65."
Answered by AI
To what extent could CPL-01 pose a risk to individuals?
"Due to the evidence collected in phase 3 trials, our team has assigned CPL-01 with a safety rating of 3 out of 3. This indicates that efficacy is supported and numerous rounds have verified its security."
Answered by AI
Could individuals enrolled in this study now?
"Presently, this clinical trial is not enrolling new patients. It was first announced on May 8th 2023 and has since been updated on April 25th of the same year. Nevertheless, there are 512 other medical studies actively recruiting candidates at present."
Answered by AI
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