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US Phase III Study of APD421 in PONV

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ClinicalTrials.gov Identifier: NCT01991860
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : September 6, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd

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.

Condition or disease Intervention/treatment Phase
PONV Drug: APD421- Amisulpride for IV injection Drug: Placebo Phase 3

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Study Type : Interventional
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
Study Start Date : August 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APD421
APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.
Drug: 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
Other Name: Amisulpride for IV injection

Placebo Comparator: Placebo
Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia
Drug: Placebo
Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia




Primary Outcome Measures :
  1. Number of Participants With Complete Response [ Time Frame: 24 hours after the end of surgery ]
    The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.


Secondary Outcome Measures :
  1. Number of Participants With no 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. "No nausea" means no score ≥ 1.

  2. Number of Participants With no Emesis [ Time Frame: 24 hours after 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)

  3. Number of Participants With no Use of Rescue Medication [ Time Frame: 24 hours after end of surgery ]
    Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.

  4. The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication [ Time Frame: 24 hours after the end of surgery ]
    No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication.

  5. The Number of Participants With no Significant 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. "No significant nausea" means no score ≥ 4.

  6. Number of Participants With "Total Response" [ Time Frame: 24 hours after the end of surgery ]
    Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication.



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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 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

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): NCT01991860


Locations
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United States, North Carolina
Duke
Durham, North Carolina, United States
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
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Principal Investigator: Tong J Gan, MD Duke University Medical College

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Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT01991860     History of Changes
Other Study ID Numbers: DP10015
First Posted: November 25, 2013    Key Record Dates
Results First Posted: September 6, 2018
Last Update Posted: February 12, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Anesthetics
Amisulpride
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents