Status:
COMPLETED
Phase II Dose-ranging Study of APD421 in PONV
Lead Sponsor:
Acacia Pharma Ltd
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 under...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT01510704
Start Date
January 1 2012
End Date
April 1 2012
Last Update
March 5 2019
Active Locations (13)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
University Hospital
Besançon, France
3
Hôpital mère enfant
Bron, France, 69500
4
Hôpital Huriez
Lille, France