NCT00895830

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

Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Acacia Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	APD405	IV
DRUG	Placebo	IV

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-05-08
• Last updated: 2011-03-29
• Results posted: 2011-03-24

Locations

18 sites across 4 countries: United States, France, Germany, Switzerland