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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02337062
Other study ID # DP10017
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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