Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
364 participants
INTERVENTIONAL
2013-08-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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APD421
APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.
APD421- Amisulpride for IV injection
APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
Placebo
Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia
Placebo
Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
Interventions
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APD421- Amisulpride for IV injection
APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
Placebo
Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Acacia Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Tong J Gan, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University Medical College
Locations
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Duke
Durham, North Carolina, United States
Countries
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Other Identifiers
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DP10015
Identifier Type: -
Identifier Source: org_study_id
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