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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Utah
Todd Bertoch
RECRUITING
Salt Lake City
Contact Information
Primary
Erol Onel
e.onel@calibiosciences.com
2038376500
Time Frame
Start Date: 2023-05-22
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 574
Treatments
Experimental: CPL-01
Local infiltration of study drug
Active_comparator: Ropivacaine HCl
Local infiltration of study drug
Placebo_comparator: Placebo
Local infiltration of study drug
Related Therapeutic Areas
Sponsors
Leads: Cali Pharmaceuticals LLC