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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 abdominoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVZ-149 Injections | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVZ-149 Injections | Drug | IV infusion of 1000 mg of VVZ-149 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence | Using Numeric Pain Rating Scale (NRS, 0-10 at rest) | 0-12 hours post-emergence |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence | 0-24 hours post-emergence | |
| Total number of requests for rescue medication for 24 hours post-emergence | 0-24 hours post-emergence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doo Lee, PhD | Vivozon, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Anaheim Clinical Trials |
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| Placebo | Drug | IV infusion of 0 mg of VVZ-149 |
|
| Total amount of rescue medication consumption for 12 hours post-emergence | 0-12 hours post-emergence |
| Total amount of intra-operative fentanyl use | During surgery |
| Anaheim |
| California |
| 92801 |
| United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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