Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

Phase 3

Completed

Conditions: PONV

Interventions: Drug: APD421
Drug: Placebo

Registration Number: NCT02337062

Lead Sponsor: Acacia Pharma Ltd

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1147

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APD421 + standard anti-emetic	APD421	Single dose of IV APD421
Placebo + standard anti-emetic	Placebo	Single dose of IV placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Response	24 hours after the end of surgery	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)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Receiving Rescue Medication	24 hours after the end of surgery	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
Number of Participants With Significant Nausea	24 hours after end of surgery	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.
Time to First Violation of Criteria for PONV	24 hours after end of surgery	Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery
Number of Participants With Emesis	24 hours after the end of surgery	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)
Number of Participants With Any Nausea	24 hours after the end of surgery	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.

Trial Locations

Locations (25): Ohio State University
🇺🇸
Columbus, Ohio, United States
Stony Brook Medicine
🇺🇸
Stony Brook, New York, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Centre Hospitalier de Mulhouse
🇫🇷
Mulhouse, France
UCSF School of Medicine
🇺🇸
San Francisco, California, United States
Helen Keller Hospital
🇺🇸
Sheffield, Alabama, United States
Centre Hospitalier Lyon-Sud
🇫🇷
Lyon, France
First Street Surgical Center
🇺🇸
Bellaire, Texas, United States
CHU de Hautepierre
🇫🇷
Strasbourg, France
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Memorial Hermann-Memorial City Hospital
🇺🇸
Houston, Texas, United States
Jackson Memorial Hospital
🇺🇸
Miami, Florida, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Albany Medical Center Hospital
🇺🇸
Albany, New York, United States
Wake Forest University School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States
Victory Medical Center Houston
🇺🇸
Houston, Texas, United States
University Hospital
🇫🇷
Besançon, France
Hopital Foch
🇫🇷
Paris, France
HELIOS Klinikum Aue
🇩🇪
Aue, Germany
Universitätsklinikum Bonn
🇩🇪
Bonn, Germany
Universitätsmedizin Mainz
🇩🇪
Mainz, Germany
Klinikum Ludwigshafen
🇩🇪
Ludwigshafen, Germany
University Hospitals of Würzburg
🇩🇪
Würzburg, Germany
Philipps University
🇩🇪
Marburg, Germany
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States