CPL-01 in the Management of Postoperative Pain After Bunionectomy

Bunion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831449
• Other study ID #: CPL-01-302
• Status: Recruiting
• Phase: Phase 3
• Start date: May 22, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: Cali Pharmaceuticals LLC
• Contact: Erol Onel
• Phone: 2038376500
• Email: e.onel[@]calibiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 574
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Pain, Postoperative

Intervention

Drug:
• Local anesthetic injection of CPL-01
Local anesthetic injection (either IP, positive control [Naropin], or negative control [saline placebo])
• Naropin, 0.5% Injectable Solution
Local anesthetic injection (either IP, positive control [Naropin], or negative control [saline placebo])
• Placebo
Local anesthetic injection (either IP, positive control [Naropin], or negative control [saline placebo])

Locations

Country	Name	City	State
United States	Todd Bertoch	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Cali Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Pain Score	Area Under the Curve of the Numeric Rating Scale Score for Pain with Activity. Activity is resting the operative foot with the ball on the floor. Pain Score spans from 0 to 10, where 0 is no pain and 10 is worst pain imaginable.	72 hours