A Phase 3 interventional study of CPL-01 and saline placebo in Postoperative Pain and Bunion, sponsored by Cali Pharmaceuticals LLC. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Cali Pharmaceuticals LLC · Phase 3, Interventional, and Treatment
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 112 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Cali Pharmaceuticals LLC is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intra-operative local administration
Drug: CPL-01
Intra-operative local administration
Drug: saline placebo
Administration by the Surgeon during the operation
Administration by the Surgeon during the operation
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)
Time frame: 24 hours
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)
Time frame: 24 hours, 72 hours
Postoperative rescue medication use
Opioid and non-opioid pain control medicines needed
Time frame: 24 hours, 72 hours
Plan to share: Yes — All IPD necessary for results
Supporting information: Study protocol
Time frame: After approval
Access criteria: As necessary
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CPL-01
Cali Pharmaceuticals LLC