Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
368 participants
INTERVENTIONAL
2013-07-31
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
IV APD421 single dose
APD421
Placebo
IV placebo single dose
Placebo
Interventions
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APD421
Placebo
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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Pierre Diemunsch, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital de Hautepierre
Locations
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CHU de Hautepierre
Strasbourg, , France
University Hospitals of Würzburg
Würzburg, , Germany
Countries
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Other Identifiers
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DP10014
Identifier Type: -
Identifier Source: org_study_id
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