Phase 3
N=347
European Phase III Study of APD421 in PONV
PONV
Bottom Line
View on ClinicalTrials.gov: NCT01991821 ↗Enrolled (actual)
347
Serious AEs
2.0%
Results posted
Aug 2019
Primary outcome: Primary: Complete Response (no Emesis, Significant Nausea or Rescue Medication) — 95; 83 Participants — p=0.093
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- APD421 (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 Complete Response (no Emesis, Significant Nausea or Rescue Medication) |
95; 83 | 0.093 |
| SECONDARY Complete Response (no Emesis or Rescue Medication) |
100; 89 | 0.059 |
| SECONDARY Total Response (no Emesis, Nausea or Rescue Medication) |
87; 73 | 0.053 |
| SECONDARY Incidence of Emesis (Vomiting/Retching) |
34; 46 | 0.26 |
| SECONDARY Incidence of Nausea |
75; 98 | 0.06 |
| SECONDARY Incidence of Significant Nausea |
63; 84 | 0.079 |
| SECONDARY Use of Rescue Medication |
62; 82 | 0.096 |
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 (NCT01991821). 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.