drugset / Trial / NCT00895830

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

NCT00895830

Phase 2 Completed 257 enrolled Acacia Pharma Ltd
RandomizedParallel-groupQuadruple-blindPrevention

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

Drugs

EvaluationDrugModalityDoseRoute
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.