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

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).,

Study Overview

• Status: Not yet recruiting
• Conditions: Post-operative Nausea and Vomiting (PONV)
• Intervention / Treatment: Drug: Aprepitant Injection; Drug: Aprepitant Injection Placebo

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 Type: Interventional
• Enrollment (Estimated): 486
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn
• Study Contact Backup: Name: xiangdong chen, Doctor of Medicine(M.D.); Phone Number: +86-027-85726300; Email: xiangdongchen2013@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aprepitant Injection; Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds	Drug: Aprepitant Injection; Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
Placebo Comparator: Placebo; Before anesthesia induction, 4.4ml(0mg）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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by NIH	Safety was assessed by Adverse events (AEs) were recorded after administration.	Day 0 to Day14

Collaborators and Investigators

• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 28, 2024
• Primary Completion (Estimated): March 28, 2026
• Study Completion (Estimated): March 28, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Aprepitant; Fosaprepitant
• Other Study ID Numbers: SYH9053-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No