Phase 3
N=342
US Phase III Study of APD421 in PONV
PONV
Bottom Line
View on ClinicalTrials.gov: NCT01991860 ↗Enrolled (actual)
342
Serious AEs
5.0%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Complete Response — 78; 54 Participants — p=0.033
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- APD421- Amisulpride for IV injection (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acacia Pharma Ltd
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response |
78; 54 | 0.033 sig |
| SECONDARY Number of Participants With no Nausea. |
82; 64 | 0.16 |
| SECONDARY Number of Participants With no Emesis |
141; 129 | 0.68 |
| SECONDARY Number of Participants With no Use of Rescue Medication |
80; 55 | 0.026 sig |
| SECONDARY The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication |
73; 53 | 0.086 |
| SECONDARY The Number of Participants With no Significant Nausea |
107; 84 | 0.074 |
| SECONDARY Number of Participants With "Total Response" |
67; 50 | 0.15 |
Summary
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01991860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.