CPL-01 in the Management of Postoperative Pain After Bunionectomy

NCT ID: NCT05831449

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2024-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CPL-01

Local infiltration of study drug

Group Type: EXPERIMENTAL

Local anesthetic injection of CPL-01

Intervention Type: DRUG

Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])

Ropivacaine HCl

Local infiltration of study drug

Group Type: ACTIVE_COMPARATOR

Naropin, 0.5% Injectable Solution

Intervention Type: DRUG

Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])

Placebo

Local infiltration of study drug

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])

Interventions

Local anesthetic injection of CPL-01

Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])

Intervention Type: DRUG

Naropin, 0.5% Injectable Solution

Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])

Intervention Type: DRUG

Placebo

Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])

Intervention Type: DRUG

Other Intervention Names

CPL-01; Long-acting ropivacaine; ropivacaine HCl; Saline placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cali Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erol Onel

Role: STUDY_DIRECTOR

Cali Biosciences

Locations

Todd Bertoch

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erol Onel

Role: CONTACT

e.onel@calibiosciences.com

2038376500

Facility Contacts

Todd Bertoch

Role: primary

Other Identifiers

CPL-01-302

Identifier Type: -

Identifier Source: org_study_id