European Phase III Study of APD421 in PONV

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01991821
• Date of registration: 11/11/2013
• Prospective Registration: No
• Primary sponsor: Acacia Pharma Ltd
• Public title: European Phase III Study of APD421 in PONV
• Scientific title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
• Date of first enrolment: July 2013
• Target sample size: 368
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01991821
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France, Germany

Contacts

• Name: Pierre Diemunsch, MD
• Affiliation: Hôpital de Hautepierre

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

PONV

Intervention(s)

Drug: Placebo

Drug: APD421

Primary Outcome(s)

Complete Response (no Emesis, Significant Nausea or Rescue Medication) [Time Frame: 24 hours after end of surgery]

Secondary Outcome(s)

Incidence of Emesis (Vomiting/Retching) [Time Frame: 24 hours after end of surgeryry]

Use of Rescue Medication [Time Frame: 24 hours after end of surgery]

Complete Response (no Emesis or Rescue Medication) [Time Frame: 24 hrs after end of surgery]

Incidence of Nausea [Time Frame: 24 hours after end of surgery]

Incidence of Significant Nausea [Time Frame: 24 hours after end of surgery]

Total Response (no Emesis, Nausea or Rescue Medication) [Time Frame: 24 hrs after end of surgery]

Secondary ID(s)

DP10014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01991821