NCT06543966

Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection in the Prevention of Post-operative Nausea and Vomiting

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,

Detailed description

In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).

Conditions

• Post-operative Nausea and Vomiting (PONV)

Interventions

Type	Name	Description
DRUG	Aprepitant Injection	Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
DRUG	Aprepitant Injection Placebo	Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds

Timeline

• Start date: 2024-10-28
• Primary completion: 2026-03-28
• Completion: 2026-03-28
• First posted: 2024-08-09
• Last updated: 2024-08-09