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

Phase 3

Not yet recruiting

• Conditions: Post-operative Nausea and Vomiting (PONV)
• Interventions: Drug: Aprepitant Injection; Drug: Aprepitant Injection Placebo

• Registration Number: NCT06543966
• Lead Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Brief 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).

Study Timeline

• Study First Submitted: 2024-07-17
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-10-28
• Primary Completion: 2026-03-28
• Study Completion: 2026-03-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

Age ≥18 and ≤75 years old; 18 < BMI≤30kg/m^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.

expected or agreed to stay in the hospital for 24 hours or more after surgery;

Exclusion Criteria

diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Complete response (CR) rates over 24 hours after the end of surgery	0-24 hours after the end of surgery	Complete response (defined as no emetic episodes and no use of rescue therapy)

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery	0-24 hours after the end of surgery	No nausea（defined as a visual analogue scale (VAS) nausea score \< 1.）
Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery	0-24 hours after the end of surgery	Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4）
Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery	0-24 hours after the end of surgery	No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery	0-48 hours after the end of surgery	No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery	0-24 hours after the end of surgery
Time to treatment failure in the 0 to 24 hours following the end of surgery	0-24 hours after the end of surgery	defined as the time to the first episode of vomiting (vomiting or retching) or the time to rescue therapy, whichever occurred first.
The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery	0-48 hours after the end of surgery