CPL-01 for managing pain after bunion surgery
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
This study is testing if a new pain medication called CPL-01 can help people feel less pain and use fewer opioids after bunion surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 574 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cali Pharmaceuticals LLC Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05831449 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of CPL-01 in reducing postoperative pain and opioid use following a bunionectomy. Participants will be randomly assigned to receive either the investigational drug, a positive control, or a negative control during their surgery. After the procedure, subjects will be monitored for 72 hours in the hospital, with follow-up assessments at 7 and 30 days to evaluate pain levels and medication usage. The goal is to determine if CPL-01 can provide better pain management compared to the other treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for elective primary unilateral distal bunionectomy with a BMI of 39 kg/m2 or less.
Not a fit: Patients who have previously undergone bunion surgery or have concurrent painful conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved pain management and reduced reliance on opioids for patients undergoing bunion surgery.
How similar studies have performed: Other studies have shown promise with similar approaches in pain management, but this specific intervention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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
Where this trial is running
Salt Lake City, Utah
- Todd Bertoch — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Erol Onel
- Email: e.onel@calibiosciences.com
- Phone: 2038376500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.