US Phase III Study of APD421 in PONV

Acacia Pharma

Status and phase: Completed; Phase 3

Conditions: PONV

Treatments: Drug: APD421- Amisulpride for IV injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01991860

DP10015

Details and patient eligibility

About

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

Enrollment: 364 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 2 patient groups, including a placebo group

APD421

Experimental group

Description:

APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.

Treatment:

Drug: APD421- Amisulpride for IV injection

Placebo

Placebo Comparator group

Description:

Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia

Treatment:

Drug: Placebo