US Phase III Study of APD421 in PONV
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | August 2013 |
| End Date: | January 2014 |
Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at
moderate-to-high risk of PONV.
moderate-to-high risk of PONV.
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
We found this trial at
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