Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

About this trial

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).,

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aprepitant Injection

    Drug

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

  • Aprepitant Injection Placebo

    Drug

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

Treatment groups

486 Participants
are divided into 2 treatment groups
Group A: Aprepitant InjectionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
0-24 hours after the end of surgery

Secondary outcomes

1

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.)

Time frame
0-24 hours after the end of surgery
2

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)

Time frame
0-24 hours after the end of surgery
3

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)

Time frame
0-24 hours after the end of surgery
4

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

Other outcomes

1

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

Safety was assessed by Adverse events (AEs) were recorded after administration.

Time frame
Day 0 to Day14

Locations

This trial has no locations.

Sponsors and contacts

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