Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
NCT04430088 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2020-07-23
Summary
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.
Conditions
- Pain, Postoperative
Interventions
- DRUG
-
VVZ-149 Injections
IV infusion of 1000 mg of VVZ-149
- DRUG
-
IV infusion of 0 mg of VVZ-149
Sponsors & Collaborators
-
Vivozon, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-26
- Primary Completion
- 2020-12-31
- Completion
- 2021-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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