Aprepitant Injection
DrugBefore anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
Not Yet Recruiting
NCT Number: 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 compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
Treatment and study plan
Aprepitant Injection Placebo
DrugBefore anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds
Primary outcomes
-
Complete response (CR) rates over 24 hours after the end of surgery
Time frame: 0-24 hours after the end of surgery
Complete response (defined as no emetic episodes and no use of rescue therapy)
Secondary outcomes
-
Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery
Time frame: 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
Time frame: 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
Time frame: 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 use the remedial treatment in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
-
Time to treatment failure in the 0 to 24 hours following the end of surgery
Time frame: 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.
-
Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery
Time frame: 0-48 hours after the end of surgery
No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
-
The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery
Time frame: 0-48 hours after the end of surgery
Other outcomes
-
Number of participants with treatment-related adverse events as assessed by NIH
Time frame: Day 0 to Day14
Safety was assessed by Adverse events (AEs) were recorded after administration.
Study contacts
Contact information is provided by the study sponsor or research team.
Clinical Trials Information Group officer
CONTACT
xiangdong chen, Doctor of Medicine(M.D.)
CONTACT
Sponsors and collaborators
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 9, 2024
- Registry last updated
- Aug 9, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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