PONV Clinical Trial
Official title:
Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
NCT number | NCT01991821 |
Other study ID # | DP10014 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2013 |
Est. completion date | January 2014 |
Verified date | August 2019 |
Source | Acacia Pharma Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
Status | Completed |
Enrollment | 368 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients = 18 years of age - Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital Exclusion Criteria: - Patients scheduled for outpatient/day case surgery - Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery - Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block - Patients who are expected to remain ventilated for a period after surgery - Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed |
Country | Name | City | State |
---|---|---|---|
France | CHU de Hautepierre | Strasbourg | |
Germany | University Hospitals of Würzburg | Würzburg |
Lead Sponsor | Collaborator |
---|---|
Acacia Pharma Ltd |
France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response (no Emesis, Significant Nausea or Rescue Medication) | The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%. | 24 hours after end of surgery | |
Secondary | Complete Response (no Emesis or Rescue Medication) | 24 hrs after end of surgery | ||
Secondary | Total Response (no Emesis, Nausea or Rescue Medication) | 24 hrs after end of surgery | ||
Secondary | Incidence of Emesis (Vomiting/Retching) | An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery | 24 hours after end of surgeryry | |
Secondary | Incidence of Nausea | Count of patients experiencing an episode of nausea scored = 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery | 24 hours after end of surgery | |
Secondary | Incidence of Significant Nausea | Count of participants with nausea score = 4 on 0-10 verbal response scale | 24 hours after end of surgery | |
Secondary | Use of Rescue Medication | 24 hours after end of surgery |
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