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Clinical Trial NCT07490496 for Postoperative Pain, Bunion is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Phase 3 Bunionectomy Study Phase 3 112

Not yet recruiting
Clinical Trial NCT07490496 is designed to study Treatment for Postoperative Pain, Bunion. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 July 2026 until the study accrues 112 participants. Led by Cali Pharmaceuticals LLC, this study is expected to complete by 28 November 2026. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
Detailed Description
After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.
Official Title

A Randomized, Double-Blind, Placebo-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

Conditions
Postoperative PainBunion
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • CPL-01-3021
NCT ID Number
NCT07490496
Start Date (Actual)
2026-07-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-11-28
Enrollment (Estimated)
112
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
bunionectomy
bunion
osteotomy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCPL-01
Intra-operative local administration
CPL-01
Administration by the Surgeon during the operation
Placebo ComparatorSaline placebo
Intra-operative local administration
saline placebo
Administration by the Surgeon during the operation
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Postoperative Pain with activity
AUC NRS-A wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain with Activity where 0 is no pain and 10 is worst pain imaginable)
24 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Postoperative Pain with rest
AUC NRS-R wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain at Rest where 0 is no pain and 10 is worst pain imaginable)
24 hours, 72 hours
Postoperative rescue medication use
Opioid and non-opioid pain control medicines needed
24 hours, 72 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Bunion

  • Concomitant conditions
Cali Pharmaceuticals LLC logoCali Pharmaceuticals LLC
Study Central Contact
Contact: Erol Onel, MD, 203-837-6500, [email protected]
1 Study Locations in 1 Countries

Utah

CenExel, Salt Lake City, Utah, 84107, United States
Todd Bertoch, MD, Contact, 801-261-2000, [email protected]