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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02449291
Date of registration: 18/05/2015
Prospective Registration: Yes
Primary sponsor: Acacia Pharma Ltd
Public title: Study of APD421 as PONV Treatment (no Prior Prophylaxis)
Scientific title: Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had no Prior Prophylaxis
Date of first enrolment: September 2015
Target sample size: 568
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02449291
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
France Germany United States
Contacts
Name:     Keith Candiotti, MD
Address: 
Telephone:
Email:
Affiliation:  University of Miami
Key inclusion & exclusion criteria

Inclusion criteria:

- Male or female patients = 18 years of age

- Provision of written informed consent

- Patients scheduled to undergo elective surgery (open or laparoscopic technique) under
general anaesthesia (other than total intravenous anaesthesia with propofol) expected
to last at least one hour from induction of anaesthesia to extubation

- Patients judged by the investigator to have a low to moderate risk of experiencing
PONV. In forming this judgment, investigators should pay particular attention to risk
factors such as a past history of PONV and/or motion sickness; habitual non-smoking
status; female sex; and likely use of opioid analgesia post-operatively

- For females of child-bearing potential: ability and willingness to use a highly
effective form of contraception (as defined in ICH M3 guidance, e.g., abstinence from
sexual intercourse, surgical sterilisation (of subject or partner), combined oral
contraceptive pill, a double-barrier method of contraception such as either an
intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with
partner's use of a condom, or any other method or combination of methods with a
failure rate generally considered to be <1% per year) between the date of screening
and at least 48 hours after administration of study drug

- In order to be eligible for randomisation, subjects must also:

(i) have experienced a first episode of PONV not more than 24 hours after the end of
their operation and prior to discharge from hospital ("qualifying PONV episode"), for
which they have not already received any anti-emetic treatment; and (ii) not have
received any agent likely to prevent or treat nausea or vomiting (given as prophylaxis
or otherwise) in the period from 12 hours prior to the start of their operation up to
the time of the qualifying PONV episode.

Exclusion Criteria:

- Patients scheduled to undergo transplant surgery or any surgery where post-operative
emesis may pose a significant danger to the patient

- Patients planned to receive only a local anaesthetic and/or regional neuraxial
(intrathecal or epidural) block

- Patients who have received APD421 active ingredient for any indication within the last
2 weeks

- Patients who are allergic to APD421 active ingredient or any of the excipients of
APD421

- Patients with a significant, ongoing history of vestibular disease or dizziness

- Patients being treated with regular anti-emetic therapy (dosed at least three times
per week), which is still ongoing within one week prior to surgery

- Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or
breast cancer) or phaeochromocytoma

- Patients being treated with levodopa

- Patients who are pregnant or breast feeding

- Patients with documented or suspected alcohol or substance abuse within the past 6
months

- Patients with a documented, clinically significant cardiac arrhythmia

- Patients diagnosed with Parkinson's disease

- Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks

- Patients with a history of epilepsy

- Any other concurrent disease or illness that, in the opinion of the investigator makes
the patient unsuitable for the study

- Patients who have previously participated in this study or who have participated in
another interventional clinical study involving pharmacological therapy within the
previous 28 days (or longer exclusion period, if required by national or local
regulations)

- Where local laws/regulations require: patients under legal protection



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Postoperative Nausea and Vomiting
Intervention(s)
Drug: APD421
Drug: Placebo
Primary Outcome(s)
Complete Response (Success of Initial PONV Treatment) [Time Frame: 0-24 hours after treatment]
Secondary Outcome(s)
Evolution Score of Nausea (0-30 Mins) [Time Frame: 0-30 minutes after study drug administration]
Maximum Severity of Nausea [Time Frame: 30 mins to 24 hours after study drug administration]
Number of Participants With Complete Response 0-2 Hrs [Time Frame: 0-2 hours after administration of study medication]
Incidence of Nausea [Time Frame: 30 mins to 24 hours after study drug administration]
Number of Participants With Complete Response 2-24 Hrs [Time Frame: 2-24 hours after administration of study medication]
Incidence of Significant Nausea [Time Frame: 30 mins to 24 hours after study drug administration]
Number of Participants Using Rescue Medication [Time Frame: 0-24 hours after study drug administration]
Time to Treatment Failure [Time Frame: 0-24 hours after study drug administration]
Number of Patients Experiencing Incidence of Emesis [Time Frame: 30 mins to 24 hours after study drug administration]
Secondary ID(s)
DP10018
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/12/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02449291
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