Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895830
• Other study ID #: DP10002
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2009
• Last updated: March 25, 2011
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2011
• Source: Acacia Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients = 18 years of age

• Written informed consent

• Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:

1. Hysterectomy (any surgical technique)

2. Cholecystectomy (any surgical technique)

3. Other elective surgery requiring overnight admission to hospital and scheduled to last at least 1 hour from induction of anaesthesia

• Patients with at least 2 risk factors for PONV, defined as 2 of the following:

1. Past history of PONV and/or motion sickness

2. Non-smoking status

3. Female gender

4. Planned opiate use for post-operative analgesia

• American Society of Anesthesiologists (ASA) risk score I-III (see Appendix 3)

• Adequate hepatic and renal function

• Alanine aminotransferase (ALT) <2.5 * upper limit normal (ULN)

• Aspartate aminotransferase (AST) <2.5 * ULN

• Bilirubin <1.5 * ULN

• Creatinine <1.5 * ULN

• Adequate haematological function

• Haemoglobin =9.5 g/dL

• White blood count 4.0-11.0 * 10^9/L

• Platelet count =150 - 400 * 10^9/L

• Ability and willingness to give written informed consent

Exclusion Criteria:

• Patients undergoing outpatient/day case surgery

• Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery

• Patients undergoing intra-thoracic, transplant or central nervous system surgery

• Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block

• Patients receiving monoamine oxidase inhibitor (MAOI) therapy currently or in the preceding 3 weeks

• Patients with a pre-existing vestibular disorder or history of dizziness

• Patients that are expected to need a naso- or oral-gastric tube in situ after surgery is completed

• Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study

• Patients treated with regular anti-emetic therapy including corticosteroids

• Patients receiving CYP3A4 inducers or inhibitors within 7 days prior to study including but not limited to erythromycin, itraconazole, nefazodone, diltiazem, verapamil, rifampicin

• Patients with pre-existing nausea or vomiting 24 hours before surgery

• Patients who are breast feeding or pregnant

• Patients with a history of alcohol abuse

• Patients diagnosed with Parkinson's disease

• Patients who have received anti-cancer chemotherapy in the previous 4 weeks

• Patients with pre-existing clinically significant cardiac arrhythmia

• Patients with a history of epilepsy

• Patients who have participated in a previous study within the last 28 days (French sites only: Patients who have participated in a previous study within the last 6 months, if required by national or local regulations)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• APD405
IV
• Placebo
IV

Locations

Country	Name	City	State
France	University Hospital	Besançon
France	Hôpital mère enfant	Bron
France	Hôpital Huriez	Lille
France	University Hospital	Nancy
France	Hôpital FOCH	Paris
France	University Hospital	Reims
France	Hautepierre Hospital	Strasbourg
Germany	Charité - Universitätsmedizin	Berlin
Germany	Universität Heidelberg	Heidelberg
Germany	University of Leipzig	Leipzig
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	Philipps University	Marburg
Germany	University Hospitals of Würzburg	Würzburg
Switzerland	Geneva University Hospitals	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United States	Duke University Medical Center	Durham	North Carolina
United States	Memorial Hermann-Memorial City Hospital	Houston	Texas
United States	UCSF Medical Center at Mt Zion	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Acacia Pharma Ltd

Countries where clinical trial is conducted

United States,  France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experienced Post-operative Nausea or Vomiting		24 hours	No