Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy

Study Overview
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Brief Summary
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The purpose of this phase 2 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 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 between the ages of 18 to 70 years, inclusive. Female subjects must meet additional criteria in relation to childbearing potential. Subjects must be undergoing a planned 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. Subjects must be classified as American Society of Anesthesiologists risk class I to II. Exclusion Criteria: Subjects undergoing emergency or unplanned surgery. Subjects undergoing a repeat operation. 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
Maximum Age: 70 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>* Other names: Opiranserin Injections;|
| 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 |
| --- | --- | --- |
| Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion | Using Numeric Pain Rating Scale (NRS, 0-10 at rest) | 0-12 hours after the start of study drug infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of pain intensity for 24 hours after the start of study drug infusion. |  | 0-24 hours after the start of study drug infusion | 
| Total opioid consumption up to 12 hours after the start of study drug infusion. |  | 0-12 hours after the start of study drug infusion | 
| Total opioid consumption up to 24 hours after the start of study drug infusion. |  | 0-24 hours after the start of study drug infusion | 
| Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point. |  | 0-24 hours after the start of study drug infusion | 
| Time until the subject requested first and second rescue medications. |  | 0-24 hours after the start of study drug infusion | 
| Time to perceptible, meaningful, and confirmed perceptible pain relief. |  | 0-12 hours after the start of study drug infusion |