Clinical trial NCT05831449: CPL-01 in the Management of Postoperative Pain After Bunionectomy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bunion
Lead sponsor: Cali Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 574
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cumulative Pain Score
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Todd Bertoch
state: Utah
Study officials:
affiliation: Cali Biosciences
name: Erol Onel
role: STUDY_DIRECTOR
References: