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Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

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ClinicalTrials.gov Identifier: NCT02337062
Recruitment Status : Completed
First Posted : January 13, 2015
Results First Posted : August 4, 2017
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
PONV Drug: APD421 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APD421 + standard anti-emetic
Single dose of IV APD421
Drug: APD421
Placebo Comparator: Placebo + standard anti-emetic
Single dose of IV placebo
Drug: Placebo



Primary Outcome Measures :
  1. Number of Participants With Complete Response [ Time Frame: 24 hours after the end of surgery ]
    Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)


Secondary Outcome Measures :
  1. Number of Participants With Emesis [ Time Frame: 24 hours after the end of surgery ]
    Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)

  2. Number of Participants Receiving Rescue Medication [ Time Frame: 24 hours after the end of surgery ]
    Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential

  3. Number of Participants With Any Nausea [ Time Frame: 24 hours after the end of surgery ]
    Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Any nausea" means a score ≥ 1.

  4. Number of Participants With Significant Nausea [ Time Frame: 24 hours after end of surgery ]
    Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Significant nausea" means a score ≥ 4.

  5. Time to First Violation of Criteria for PONV [ Time Frame: 24 hours after end of surgery ]
    Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337062


Locations
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United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, California
UCSF School of Medicine
San Francisco, California, United States, 94143
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Albany Medical Center Hospital
Albany, New York, United States, 12208
Stony Brook Medicine
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
First Street Surgical Center
Bellaire, Texas, United States, 77401
Victory Medical Center Houston
Houston, Texas, United States, 77004
Memorial Hermann-Memorial City Hospital
Houston, Texas, United States, 77024
France
University Hospital
Besançon, France, 25030
Centre Hospitalier Lyon-Sud
Lyon, France, 69495
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Hopital Foch
Paris, France
CHU de Hautepierre
Strasbourg, France
Germany
HELIOS Klinikum Aue
Aue, Germany, 08280
Universitätsklinikum Bonn
Bonn, Germany, 53127
Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063
Universitätsmedizin Mainz
Mainz, Germany, 55131
Philipps University
Marburg, Germany, 35033
University Hospitals of Würzburg
Würzburg, Germany
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
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Principal Investigator: Peter Kranke, MD Würzburg University Hospitals

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Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT02337062     History of Changes
Other Study ID Numbers: DP10017
First Posted: January 13, 2015    Key Record Dates
Results First Posted: August 4, 2017
Last Update Posted: March 20, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents