NCT01510704: Phase II Dose-ranging Study of APD421 in PONV

Summary

To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

Timeline

Start: 2012-01
Primary completion: 2012-04
Completion: 2012-04

Outcome

Met primary endpoint

paper The PONV incidence was 37/54 [69%; 90% confidence interval (CI), 57-79%] in the placebo group; 28/58 (48%; 90% CI, 37-60%) with 1 mg APD421 (P=0.048) PMID 23872464 ↗

paper 20/50 (40%; 90% CI, 28-53%) with 5 mg (P=0.006) PMID 23872464 ↗

Publications

Kranke P, Eberhart L, Motsch J, Chassard D, Wallenborn J, Diemunsch P, Liu N, Keh D, Bouaziz H, Bergis M, Fox G, Gan TJ. I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013 Dec;111(6):938-45. doi: 10.1093/bja/aet251. Epub 2013 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amisulpride	Small molecule	1 mg	Intravenous
Subject	Amisulpride	Small molecule	5 mg	Intravenous
Subject	Amisulpride	Small molecule	20 mg	Intravenous

Indications

No indication recorded.