European Phase III Study of APD421 in PONV

Phase 3

Completed

• Conditions: PONV
• Interventions: Drug: APD421; Drug: Placebo

• Registration Number: NCT01991821
• Lead Sponsor: Acacia Pharma Ltd

Brief Summary

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2019-06-14
• Results First Submitted QC: 2019-06-14
• Status Verified: 2019-08
• Results First Posted: 2019-08-02
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• Male or female patients ≥ 18 years of age
• Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Exclusion Criteria

• Patients scheduled for outpatient/day case surgery
• Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
• Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
• Patients who are expected to remain ventilated for a period after surgery
• Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APD421	APD421	IV APD421 single dose
Placebo	Placebo	IV placebo single dose

Primary Outcome Measures

Name	Time	Method
Complete Response (no Emesis, Significant Nausea or Rescue Medication)	24 hours after end of surgery	The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.

Secondary Outcome Measures

Name	Time	Method
Total Response (no Emesis, Nausea or Rescue Medication)	24 hrs after end of surgery
Use of Rescue Medication	24 hours after end of surgery
Complete Response (no Emesis or Rescue Medication)	24 hrs after end of surgery
Incidence of Emesis (Vomiting/Retching)	24 hours after end of surgeryry	An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery
Incidence of Significant Nausea	24 hours after end of surgery	Count of participants with nausea score ≥ 4 on 0-10 verbal response scale
Incidence of Nausea	24 hours after end of surgery	Count of patients experiencing an episode of nausea scored ≥ 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery

Trial Locations

Locations (2)

CHU de Hautepierre; 🇫🇷 Strasbourg, France

University Hospitals of Würzburg; 🇩🇪 Würzburg, Germany