Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)

Summary

To assess the efficacy and safety of different doses of APD405 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

2009-05

Primary completion

2009-11

Completion

2009-11

Outcome

Missed primary endpoint

paper With buspirone, that incidence ranged from a mean of 40.8 % (29.3-52.4 %) in the 1 mg arm to 58.0 % (46.5-69.5 %) in the 0.3 mg arm (P > 0.05 for all comparisons). PMID 22546895 ↗

paper We were unable to show that intravenous single-dose buspirone, at the tested dose-range, was effective at preventing PONV in surgical adult patients. PMID 22546895 ↗

Publications

• Kranke P, Rohm KD, Diemunsch P, Gan TJ, Apfel CC, Eberhart L, Minkowitz HS, Wallenborn J, Chassard D, Lebuffe G, Fox GM, Tramer MR. Intravenous buspirone for the prevention of postoperative nausea and vomiting. Eur J Clin Pharmacol. 2012 Nov;68(11):1465-72. doi: 10.1007/s00228-012-1284-8. Epub 2012 May 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buspirone	Small molecule	0.3 mg	—
Subject	Buspirone	Small molecule	1 mg	—
Subject	Buspirone	Small molecule	2 mg	—
Subject	Buspirone	Small molecule	3 mg	—

Indications

No indication recorded.