Phase II Dose-ranging Study of APD421 in PONV

NCT01510704 | Completed Phase 2 Results

• 1 other identifier: DP10006
• Study Type: interventional
• Target: 215
• Locations: 3 countries
• Sites: 13

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 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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Post-operative Nausea or Vomiting

  24 hours

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Low dose APD421

EXPERIMENTAL

1mg dose level

Drug: APD421

Mid Dose APD421

EXPERIMENTAL

5mg dose level

Drug: APD421

High Dose APD421

EXPERIMENTAL

20mg dose level

Drug: APD421

Interventions

APD421 DRUG

IV

High Dose APD421; Low dose APD421; Mid Dose APD421

Placebo DRUG

IV

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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 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

Sponsors & Collaborators

• Acacia Pharma Ltd: lead

Study Sites (13)

Duke University Medical Center

Durham, North Carolina, 27710, 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

Hautepierre Hospital

Strasbourg, 67000, France

Location

HELIOS Klinikum Aue

Aue, Germany

Location

Charité - Universitätsmedizin

Berlin, Germany

Location

Universität Heidelberg

Heidelberg, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, Germany

Location

Philipps University

Marburg, Germany

Location

University Hospitals of Würzburg

Würzburg, Germany

Location

Related Publications (1)

• Kranke P, Eberhart L, Motsch J, Chassard D, Wallenborn J, Diemunsch P, Liu N, Keh D, Bouaziz H, Bergis M, Fox G, Gan TJ. I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013 Dec;111(6):938-45. doi: 10.1093/bja/aet251. Epub 2013 Jul 19.

  PMID: 23872464 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Results Point of Contact

• Title: Dr Gabriel Fox
• Organization: Acacia Pharma Ltd

gabrielfox@acaciapharma.com

Study Officials

• Peter Kranke, MD

  University Hospitals of Würzburg

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 16, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 5, 2019
• Results First Posted: July 18, 2013

Record last verified: 2019-02

Locations

FR (6); US (1); DE (6)