Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acacia Pharma Ltd
• Treatments: Antiemetics

Criteria

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

• Patients with at least 3 "Apfel" risk factors for PONV

Exclusion Criteria:

• Patients scheduled to undergo transplant 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