- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510704
Phase II Dose-ranging Study of APD421 in PONV
February 14, 2019 updated by: Acacia Pharma Ltd
Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting
To assess the efficacy and safety of different doses of APD421 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)
215
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
-
-
-
Besançon, France
- University Hospital
-
Bron, France, 69500
- Hopital Mère Enfant
-
Lille, France
- Hopital Huriez
-
Nancy, France
- University Hospital
-
Paris, France
- Hopital Foch
-
Strasbourg, France, 67000
- Hautepierre Hospital
-
-
-
-
-
Aue, Germany
- Helios Klinikum Aue
-
Berlin, Germany
- Charité - Universitätsmedizin
-
Heidelberg, Germany
- Universität Heidelberg
-
Ludwigshafen, Germany
- Klinikum Ludwigshafen
-
Marburg, Germany
- Philipps University
-
Würzburg, Germany
- University Hospitals of Würzburg
-
-
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
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
- Ability and willingness to give 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 of the following risk factors for PONV:
- Past history of PONV and/or motion sickness
- Habitual non-smoking status
- Female sex
- Expected to receive opioid analgesia post-operatively
- American Society of Anesthesiologists (ASA) risk score I-III
Adequate cardiac, hepatic and renal function
- QTc interval < 500 ms
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN)
- Bilirubin < 3 x ULN
- Creatinine < 2 x ULN
Adequate haematological function
- Haemoglobin ≥ 9 g/dL
- White blood count ≥ 3.0 x 109/L
- Platelet count ≥ 100 x 109/L
- For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) between the date of screening and at least 48 hours after administration of study drug.
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 who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
- Patients receiving the active ingredient of APD421 for any indication within the last 2 weeks
- Patients who are allergic to the active ingredient or any of the excipients of APD421
- Patients with a pre-existing vestibular disorder or history of dizziness
- Patients with pre-existing nausea or vomiting in the 24 hours before surgery
- Patients treated with regular anti-emetic therapy including corticosteroids
- Patients being treated with medications which could induce torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin
- Patients being treated with levodopa
- Patients who are pregnant or breast feeding
- Patients with a history of alcohol abuse
- Patients with pre-existing, clinically significant cardiac arrhythmia
- Patients diagnosed with Parkinson's disease
- Patients who have received anti-cancer chemotherapy in the previous 4 weeks
- Patients with a history of epilepsy
- Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- 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: Placebo
|
IV
|
Experimental: Low dose APD421
1mg dose level
|
IV
|
Experimental: Mid Dose APD421
5mg dose level
|
IV
|
Experimental: High Dose APD421
20mg dose level
|
IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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: Peter Kranke, MD, University Hospitals of Würzburg
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
January 1, 2012
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
January 12, 2012
First Submitted That Met QC Criteria
January 12, 2012
First Posted (Estimate)
January 16, 2012
Study Record Updates
Last Update Posted (Actual)
March 5, 2019
Last Update Submitted That Met QC Criteria
February 14, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DP10006
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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