Clinical trial NCT06543966: Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Post-operative Nausea and Vomiting (PONV)
Lead sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parrallel Assignment
Primary purpose: TREATMENT

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).

Eligibility criteria: 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;

Primary outcomes:
measure: Complete response (CR) rates over 24 hours after the end of surgery
timeFrame: 0-24 hours after the end of surgery
Secondary outcomes:
measure: Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery
timeFrame: 0-24 hours after the end of surgery
measure: Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery
timeFrame: 0-24 hours after the end of surgery
measure: Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery
timeFrame: 0-24 hours after the end of surgery
measure: Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery
timeFrame: 0-24 hours after the end of surgery
measure: Time to treatment failure in the 0 to 24 hours following the end of surgery
timeFrame: 0-24 hours after the end of surgery
measure: Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery
timeFrame: 0-48 hours after the end of surgery
measure: The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery
timeFrame: 0-48 hours after the end of surgery
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by NIH
timeFrame: Day 0 to Day14
Locations:
Study officials:
References: