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

NCT04430088 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Vivozon, Inc.
Phase	Phase 3
Status	UNKNOWN
Enrolment	300
Start date	2020-06-26
Completion	2021-01

Conditions

• Pain, Postoperative

Interventions

• VVZ-149 Injections
• Placebo

Primary outcomes

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

Countries

United States