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A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APD421 + standard anti-emetic | Experimental | Single dose of IV APD421 |
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| Placebo + standard anti-emetic | Placebo Comparator | Single dose of IV placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD421 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure) | 24 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Emesis | Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach) | 24 hours after the end of surgery |
| Number of Participants Receiving Rescue Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Kranke, MD | Würzburg University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States | ||
| UCSF School of Medicine |
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Study start date:- 12th February 2015 (first patient in)
Study completion date:- 28th September 2015 (last patient last visit)
Location:-France, Germany and the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | APD421 + Standard Anti-emetic | APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic. |
| FG001 | Placebo + Standard Anti-emetic |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential |
| 24 hours after the end of surgery |
| Number of Participants With Any Nausea | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Any nausea" means a score ≥ 1. | 24 hours after the end of surgery |
| Number of Participants With Significant Nausea | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Significant nausea" means a score ≥ 4. | 24 hours after end of surgery |
| Time to First Violation of Criteria for PONV | Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery | 24 hours after end of surgery |
| San Francisco |
| California |
| 94143 |
| United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Albany Medical Center Hospital | Albany | New York | 12208 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| First Street Surgical Center | Bellaire | Texas | 77401 | United States |
| Victory Medical Center Houston | Houston | Texas | 77004 | United States |
| Memorial Hermann-Memorial City Hospital | Houston | Texas | 77024 | United States |
| University Hospital | Besançon | 25030 | France |
| Centre Hospitalier Lyon-Sud | Lyon | 69495 | France |
| Centre Hospitalier de Mulhouse | Mulhouse | 68051 | France |
| Hopital Foch | Paris | France |
| CHU de Hautepierre | Strasbourg | France |
| HELIOS Klinikum Aue | Aue | 08280 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Klinikum Ludwigshafen | Ludwigshafen | 67063 | Germany |
| Universitätsmedizin Mainz | Mainz | 55131 | Germany |
| Philipps University | Marburg | 35033 | Germany |
| University Hospitals of Würzburg | Würzburg | Germany |
Matching Placebo administered as a single, slow push, IV push over one minute at the time of induction anaesthesia given in combination with standard anti-emetic |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | APD421 + Standard Anti-emetic | Single dose of IV APD421 APD421 |
| BG001 | Placebo + Standard Anti-emetic | Single dose of IV placebo Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Complete Response | Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure) | Modified intent-to-treat | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
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| Secondary | Number of Participants With Emesis | Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach) | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
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| Secondary | Number of Participants Receiving Rescue Medication | Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
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| Secondary | Number of Participants With Any Nausea | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Any nausea" means a score ≥ 1. | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
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| Secondary | Number of Participants With Significant Nausea | Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Significant nausea" means a score ≥ 4. | Posted | Count of Participants | Participants | 24 hours after end of surgery |
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| Secondary | Time to First Violation of Criteria for PONV | Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery | Posted | Median | Inter-Quartile Range | minutes | 24 hours after end of surgery |
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For the 7 day period after study drug administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | APD421 + Standard Anti-emetic | Single dose of IV APD421 APD421 | 1 | 572 | 14 | 572 | 111 | 572 |
| EG001 | Placebo + Standard Anti-emetic | Single dose of IV placebo Placebo | 0 | 575 | 14 | 575 | 120 | 575 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Wound Secretion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Herpatic Haematoma | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Pelvic Organ Injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Postoerative ileus | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Post Operative wound infections | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Staphylococcal infections | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Small intestinal Obstruction | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
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There were no limitations and caveats that occurred during the duration of this study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gabriel Fox | Acacia Pharma Ltd | 44-(0)1223-919764 | GabrielFox@acaciapharma.com |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| Male |
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| France |
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| Germany |
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