Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

PONV Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337062
• Other study ID #: DP10017
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: March 2019
• Source: Acacia Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1147
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• 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

• Patients with at least 3 "Apfel" risk factors for PONV

Exclusion Criteria:

• Patients scheduled to undergo transplant 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

Related Conditions & MeSH terms

• PONV
• Postoperative Nausea and Vomiting

Intervention

Drug:
• APD421

• Placebo

Locations

Country	Name	City	State
France	University Hospital	Besançon
France	Centre Hospitalier Lyon-Sud	Lyon
France	Centre Hospitalier de Mulhouse	Mulhouse
France	Hopital Foch	Paris
France	CHU de Hautepierre	Strasbourg
Germany	HELIOS Klinikum Aue	Aue
Germany	Universitätsklinikum Bonn	Bonn
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	Universitätsmedizin Mainz	Mainz
Germany	Philipps University	Marburg
Germany	University Hospitals of Würzburg	Würzburg
United States	Albany Medical Center Hospital	Albany	New York
United States	First Street Surgical Center	Bellaire	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Memorial Hermann-Memorial City Hospital	Houston	Texas
United States	Victory Medical Center Houston	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Jackson Memorial Hospital	Miami	Florida
United States	UCSF School of Medicine	San Francisco	California
United States	Helen Keller Hospital	Sheffield	Alabama
United States	Stony Brook Medicine	Stony Brook	New York
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Acacia Pharma Ltd

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Response	Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)	24 hours after the end of surgery
Secondary	Number of Participants With Emesis	Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)	24 hours after the end of surgery
Secondary	Number of Participants Receiving Rescue Medication	Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential	24 hours after the end of surgery
Secondary	Number of Participants With Any Nausea	Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Any nausea" means a score = 1.	24 hours after the end of surgery
Secondary	Number of Participants With Significant Nausea	Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Significant nausea" means a score = 4.	24 hours after end of surgery
Secondary	Time to First Violation of Criteria for PONV	Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery	24 hours after end of surgery