Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

Acacia Pharma

Status and phase: Completed; Phase 3

Conditions: PONV

Treatments: Drug: Placebo; Drug: APD421

Study type: Interventional

Funder types: Industry

Identifiers

NCT02337062

DP10017

Details and patient eligibility

About

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).

Enrollment: 1,147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,147 participants in 2 patient groups, including a placebo group

APD421 + standard anti-emetic

Experimental group

Description:

Single dose of IV APD421

Treatment:

Drug: APD421

Placebo + standard anti-emetic

Placebo Comparator group

Description:

Single dose of IV placebo

Treatment:

Drug: Placebo