Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy

Study Overview
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Brief Summary
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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 bunionectomy.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: VVZ-149 Injections
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential. Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal fixation (Austin bunionectomy) without collateral procedures. Subjects must have the ability to provide written informed consent. Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff. Key Exclusion Criteria: Subjects undergoing emergency or unplanned surgery. Subjects who had any previous bunionectomy procedure on either foot. Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery. Female subjects who are pregnant or breastfeeding. Diagnosis of chronic pain and ongoing or frequent use of pain medications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VVZ-149 Injections<br> | Drug: VVZ-149 Injections<br>* IV infusion of 1000 mg of VVZ-149<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* IV infusion of 0 mg of VVZ-149<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose) | Using Numeric Pain Rating Scale (NRS, 0-10) | 0-12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of perceptible pain relief using the double stopwatch method |  | 0-12 hours post-dose | 
| Total number of rescue medication request between 0-12 hours post-dose |  | 0-12 hours post-dose | 
| Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose |  | 0-6 hours post-dose | 
| Proportion of patients who take prescription opioid after discharge |  | 2 weeks after discharge |