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APD405 for Prevention of Post-operative Nausea and Vomiting
NCT00895830Phase 2
Key facts
- Status
- Completed
- Start
- May 2009
- Primary completion
- Nov 2009
- Countries
- 4
- Sponsor
- Acacia Pharma Group Plc
- Modality
- Small Molecules
- Drugs
- amisulpride
- Conditions
- postoperative nausea and vomiting (PONV)
01
Overview
Phase 2, randomised, double-blind trial of amisulpride in postoperative nausea and vomiting (PONV) (5 arms), sponsored by Acacia Pharma Group Plc. Primary endpoint: Experienced Post-operative Nausea or Vomiting at 24 hours. Started May 2009; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo IV
APD405 0.3mg
APD405 0.3mg IV
APD405 1mg
APD405 1mg IV
APD405 2mg
APD405 2mg IV
APD405 3mg
APD405 3mg IV
03
Who it enrols
Adult patients undergoing elective surgery under general anesthesia requiring overnight stay, with at least 2 risk factors for PONV.
04
Endpoints
Primary
Experienced Post-operative Nausea or Vomiting
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