- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00895830
Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)
March 25, 2011 updated by: Acacia Pharma Ltd
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
257
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Besançon, France
- University Hospital
-
Bron, France, 69500
- Hopital Mère Enfant
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Lille, France
- Hopital Huriez
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Nancy, France
- University Hospital
-
Paris, France
- Hôpital FOCH
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Reims, France
- University Hospital
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Strasbourg, France, 67000
- Hautepierre Hospital
-
-
-
-
-
Berlin, Germany
- Charité - Universitätsmedizin
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Heidelberg, Germany
- Universitat Heidelberg
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Leipzig, Germany
- University of Leipzig
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Ludwigshafen, Germany
- Klinikum Ludwigshafen
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Marburg, Germany
- Philipps University
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Würzburg, Germany
- University Hospitals of Würzburg
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-
-
-
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Geneva, Switzerland
- Geneva University Hospitals
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Lausanne, Switzerland
- Centre Hospitalier Universitaire Vaudois
-
-
-
-
California
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San Francisco, California, United States, 94115
- UCSF Medical Center at Mt Zion
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Texas
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Houston, Texas, United States, 77024
- Memorial Hermann-Memorial City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
|
IV
|
Experimental: 2
0.3mg dose level
|
IV
|
Experimental: 3
1mg dose level
|
IV
|
Experimental: 4
2mg dose level
|
IV
|
Experimental: 5
3mg dose level
|
IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Experienced Post-operative Nausea or Vomiting
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Tramèr, MD, University Hospital, Geneva
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
May 7, 2009
First Submitted That Met QC Criteria
May 7, 2009
First Posted (Estimate)
May 8, 2009
Study Record Updates
Last Update Posted (Estimate)
March 29, 2011
Last Update Submitted That Met QC Criteria
March 25, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DP10002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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