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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02337062 |
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Date of registration:
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09/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
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Scientific title:
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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 |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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1147 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02337062 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Germany
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United States
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Contacts
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Name:
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Peter Kranke, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Würzburg University Hospitals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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PONV
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Intervention(s)
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Drug: APD421
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Drug: Placebo
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Primary Outcome(s)
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Number of Participants With Complete Response
[Time Frame: 24 hours after the end of surgery]
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Secondary Outcome(s)
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Number of Participants With Emesis
[Time Frame: 24 hours after the end of surgery]
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Number of Participants With Any Nausea
[Time Frame: 24 hours after the end of surgery]
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Time to First Violation of Criteria for PONV
[Time Frame: 24 hours after end of surgery]
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Number of Participants Receiving Rescue Medication
[Time Frame: 24 hours after the end of surgery]
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Number of Participants With Significant Nausea
[Time Frame: 24 hours after end of surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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