Phase 3
N=1,147
Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
PONV
Bottom Line
View on ClinicalTrials.gov: NCT02337062 ↗Enrolled (actual)
1,147
Serious AEs
2.4%
Results posted
Aug 2017
Primary outcome: Primary: Number of Participants With Complete Response — 330; 268 Participants — p=<0.001
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
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response |
330; 268 | <0.001 sig |
| SECONDARY Number of Participants With Emesis |
79; 115 | 0.003 sig |
| SECONDARY Number of Participants Receiving Rescue Medication |
234; 284 | 0.002 sig |
| SECONDARY Number of Participants With Any Nausea |
286; 335 | 0.002 sig |
| SECONDARY Number of Participants With Significant Nausea |
212; 274 | <0.001 sig |
| SECONDARY Time to First Violation of Criteria for PONV |
NA; 821.0 | <0.001 sig |
Summary
A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (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
- Patients with at least 3 "Apfel" risk factors for PONV
Exclusion Criteria
- Patients scheduled to undergo transplant 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 (NCT02337062). 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.