CPL-01 in the Management of Postoperative Pain After Bunionectomy
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
Sponsor: Cali Pharmaceuticals LLC
A observational or N/A phase clinical study on Bunion and Post-operative Pain, this trial is completed. The trial is conducted by Cali Pharmaceuticals LLC and has accumulated 5 data snapshots since 2023. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
5 versions recorded-
May 4, 2026 — Present [daily]
Completed
Status: Recruiting → Completed · Phase: PHASE3 → None
-
Sep 2024 — May 2026 [monthly]
Recruiting PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
-
Sep 2023 — Jul 2024 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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May 2023 — Sep 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Cali Pharmaceuticals LLC
For direct contact, visit the study record on ClinicalTrials.gov .