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History of Changes for Study: NCT01991860
US Phase III Study of APD421 in PONV
Latest version (submitted January 18, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 18, 2013 None (earliest Version on record)
2 January 9, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 July 28, 2016 Study Status
4 September 5, 2018 Study Status, More Information, Outcome Measures, Adverse Events, Baseline Characteristics and Participant Flow
5 January 18, 2019 Outcome Measures, Arms and Interventions and Study Status
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Study NCT01991860
Submitted Date:  November 18, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: DP10015
Brief Title: US Phase III Study of APD421 in PONV
Official Title: Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2013
Overall Status: Recruiting
Study Start: August 2013
Primary Completion: December 2013 [Anticipated]
Study Completion: December 2013 [Anticipated]
First Submitted: November 11, 2013
First Submitted that
Met QC Criteria:
November 18, 2013
First Posted: November 25, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 18, 2013
Last Update Posted: November 25, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Acacia Pharma Ltd
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
Detailed Description:
Open or close this module Conditions
Conditions: PONV
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 340 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: APD421
Single dose of IV APD421
Drug: APD421
Placebo Comparator: Placebo
Single dose of IV placebo
Drug: Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Complete Response (protection from PONV)
[ Time Frame: 24 hours ]

Proportion of patients with no PONV in the 24-hour period after end of surgery
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Gabriel Fox, MB BChir
Email: gabrielfox@acaciapharma.com
Study Officials: Tong J Gan, MD
Principal Investigator
Duke University Medical College
Locations: United States, North Carolina
Duke
[Recruiting]
Durham, North Carolina, United States
Contact:Contact: Tong J Gan
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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