Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | February 2015 |
| End Date: | September 2015 |
Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients
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).
in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting
(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
- 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
We found this trial at
15
sites
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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