Phase 3 Bunionectomy Study

Cali Pharmaceuticals

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Postoperative Pain; Bunion

Treatments: Drug: saline placebo; Drug: CPL-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT07490496

CPL-01-3021

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bunion

Exclusion criteria

• Concomitant conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups, including a placebo group

CPL-01

Experimental group

Description:

Intra-operative local administration

Treatment:

Drug: CPL-01

Saline placebo

Placebo Comparator group

Description:

Intra-operative local administration

Treatment:

Drug: saline placebo