NCT01510704

Phase II Dose-ranging Study of APD421 in PONV

Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (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 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.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	APD421	IV
DRUG	Placebo	IV

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-01-16
• Last updated: 2019-03-05
• Results posted: 2013-07-18

Locations

13 sites across 3 countries: United States, France, Germany