Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

257

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2009

Shorter than P25 for phase_2

Geographic Reach

4 countries

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

May 1, 2009

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

March 24, 2011

Completed

Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

6 months

First QC Date

May 7, 2009

Results QC Date

February 24, 2011

Last Update Submit

March 25, 2011

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

Experienced Post-operative Nausea or Vomiting
24 hours

Study Arms (5)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

0.3mg dose level

Drug: APD405

3

EXPERIMENTAL

1mg dose level

Drug: APD405

4

EXPERIMENTAL

2mg dose level

Drug: APD405

5

EXPERIMENTAL

3mg dose level

Drug: APD405

Interventions

APD405DRUG

2345

PlaceboDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:
Hysterectomy (any surgical technique)
Cholecystectomy (any surgical technique)
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:
Past history of PONV and/or motion sickness
Non-smoking status
Female gender
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
+7 more criteria

You may not qualify if:

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
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Acacia Pharma Ltdlead

Study Sites (18)

UCSF Medical Center at Mt Zion

San Francisco, California, 94115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Memorial Hermann-Memorial City Hospital

Houston, Texas, 77024, United States

Location

University Hospital

Besançon, France

Location

Hôpital mère enfant

Bron, 69500, France

Location

Hôpital Huriez

Lille, France

Location

University Hospital

Nancy, France

Location

Hôpital FOCH

Paris, France

Location

University Hospital

Reims, France

Location

Hautepierre Hospital

Strasbourg, 67000, France

Location

Charité - Universitätsmedizin

Berlin, Germany

Location

Universität Heidelberg

Heidelberg, Germany

Location

University of Leipzig

Leipzig, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, Germany

Location

Philipps University

Marburg, Germany

Location

University Hospitals of Würzburg

Würzburg, Germany

Location

Geneva University Hospitals

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Related Publications (1)

Kranke P, Rohm KD, Diemunsch P, Gan TJ, Apfel CC, Eberhart L, Minkowitz HS, Wallenborn J, Chassard D, Lebuffe G, Fox GM, Tramer MR. Intravenous buspirone for the prevention of postoperative nausea and vomiting. Eur J Clin Pharmacol. 2012 Nov;68(11):1465-72. doi: 10.1007/s00228-012-1284-8. Epub 2012 May 1.
PMID: 22546895DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Results Point of Contact

Title: Dr Gabriel Fox
Organization: Acacia Pharma Ltd

Study Officials

Martin Tramèr, MD
University Hospital, Geneva
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 29, 2011

Results First Posted

March 24, 2011

Record last verified: 2011-03

Locations

FR(7)DE(6)CH(2)US(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

1

2

3

4

5

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations