Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty

Vivozon

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Placebo; Drug: VVZ-149 Injections

Study type: Interventional

Funder types: Industry

Identifiers

NCT03997838

VVZ149-POP-P3-US003

Details and patient eligibility

About

The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following abdominoplasty.

Enrollment: 307 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women between 18-70 years old, inclusive. Female subjects must meet additional criteria according to childbearing potential.
• Planning to undergo abdominoplasty
• Ability to provide written informed consent
• Ability to understand study procedures and communicate clearly with the investigator and staff
• American Society of Anesthesiologists (ASA) risk class of I to II.

Exclusion criteria

• Emergency or unplanned surgery
• Previous abdominoplasty
• Pre-existing condition causing preoperative pain around the site of surgery
• Women who are pregnant or breastfeeding
• Chronic pain diagnosis and ongoing or frequent use of pain medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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307 participants in 2 patient groups, including a placebo group

VVZ-149 Injections

Experimental group

Treatment:

Drug: VVZ-149 Injections

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo