Trials / Completed
CompletedNCT01991860
US Phase III Study of APD421 in PONV
Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 364 (actual)
- Sponsor
- Acacia Pharma Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APD421- Amisulpride for IV injection | APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia |
| DRUG | Placebo | Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2014-01-01
- Completion
- 2014-01-01
- First posted
- 2013-11-25
- Last updated
- 2019-02-12
- Results posted
- 2018-09-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01991860. Inclusion in this directory is not an endorsement.