Phase 3 Bunionectomy Study

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Cali Pharmaceuticals LLC
Study ID
NCT07490496
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Bunion
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CPL-01 — DRUG
    Administration by the Surgeon during the operation
  • saline placebo — DRUG
    Administration by the Surgeon during the operation

Study Details

Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Oct 30, 2026
Completion
Nov 28, 2026

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CPL-01
    Intra-operative local administration
  • Placebo Comparator: Saline placebo
    Intra-operative local administration

Primary Outcome Measure

Postoperative Pain with activity [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CenExelSalt Lake CityUtah84107
Todd Bertoch, MD
[email protected]
801-261-2000

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By research site
CenExel· Salt Lake City, UT

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