Status:
NOT_YET_RECRUITING
Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting
Lead Sponsor:
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Conditions:
Post-operative Nausea and Vomiting (PONV)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 vomit...
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2026
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT06543966
Start Date
October 28 2024
End Date
March 28 2026
Last Update
August 9 2024
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