NCT06543966

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).,

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
486

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 28, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2026

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

July 17, 2024

Last Update Submit

August 5, 2024

Conditions

Post-operative Nausea and Vomiting (PONV)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • +2 more secondary outcomes

Other Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by NIH

    Day 0 to Day14

Study Arms (2)

Aprepitant Injection

EXPERIMENTAL

Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds

Drug: Aprepitant Injection

Placebo

PLACEBO COMPARATOR

Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds

Drug: Aprepitant Injection Placebo

Interventions

Aprepitant InjectionDRUG

Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds

Aprepitant Injection
Aprepitant Injection PlaceboDRUG

Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

xiangdong chen, Doctor of Medicine(M.D.)

CONTACT

+86-027-85726300xiangdongchen2013@163.com

Clinical Trials Information Group officer

CONTACT

86-0311-69085587ctr-contact@cspc.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parrallel Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

August 9, 2024

Study Start

October 28, 2024

Primary Completion

March 28, 2026

Study Completion

March 28, 2026

Last Updated

August 9, 2024

Record last verified: 2024-08