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A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APD421 | Experimental | APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia. |
|
| Placebo | Placebo Comparator | Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD421- Amisulpride for IV injection | Drug | APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%. | 24 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With no 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. "No nausea" means no score ≥ 1. | 24 hours after end of surgery |
| Number of Participants With no Emesis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tong J Gan, MD | Duke University Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke | Durham | North Carolina | United States |
Of the 364 patients enrolled in the study (i.e. signed informed consent form), 22 patients were not randomised and not dosed. Of these, 4 withdrew their consent, 3 did not comply with the protocol procedures and 15 were not dosed for other unspecified reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | 5mg APD421 | A 5mg (2mL) dose of APD421 given by slow intravenous (IV) push over one minute at induction of anaesthesia |
| FG001 | Placebo | 2mL of placebo given by slow intravenous (IV) push over one minute at induction of anaesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 342 patients were randomised and dosed, comprising 176 randomised to APD421 and 166 to placebo. Of these, 4 patients from the APD421 group and 2 patients from the placebo group discontinued prematurely after randomisation
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| ID | Title | Description |
|---|---|---|
| BG000 | 5mg Dose APD421 | A 5mg dose of APD421 given by slow push, single intravenous (IV) administration over a time frame of one minute at induction of anaesthesia |
| BG001 | Placebo | Single dose placebo given through intravenous (IV) administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%. | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
|
7 days
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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 5mg Dose | A 5mg dose of APD421 given by slow push, single intravenous (IV) administration over a time frame of one minute at induction of anaesthesia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
There were no limitations and caveats in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gabriel Fox | Acacia Pharma Ltd | 44-(0)1223-919764 | Gabrielfox@acaciapharma.com |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D007275 | Injections, Intravenous |
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Placebo | Drug | Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia |
|
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 end of surgery |
| Number of Participants With no Use of Rescue Medication | Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue. | 24 hours after end of surgery |
| The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication | No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication. | 24 hours after the end of surgery |
| The Number of Participants With no 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. "No significant nausea" means no score ≥ 4. | 24 hours after the end of surgery |
| Number of Participants With "Total Response" | Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication. | 24 hours after the end of surgery |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Number of Participants With no 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. "No nausea" means no score ≥ 1. | Posted | Count of Participants | Participants | 24 hours after end of surgery |
|
|
|
|
| Secondary | Number of Participants With no 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 end of surgery |
|
|
|
|
| Secondary | Number of Participants With no Use of Rescue Medication | Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue. | Posted | Count of Participants | Participants | 24 hours after end of surgery |
|
|
|
|
| Secondary | The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication | No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication. | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
|
|
|
|
| Secondary | The Number of Participants With no 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. "No significant nausea" means no score ≥ 4. | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
|
|
|
|
| Secondary | Number of Participants With "Total Response" | Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication. | Posted | Count of Participants | Participants | 24 hours after the end of surgery |
|
|
|
|
| 0 |
| 176 |
| 8 |
| 176 |
| 169 |
| 176 |
| EG001 | Placebo | Placebo given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia | 0 | 166 | 9 | 166 | 160 | 166 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Post Procedural Constipation | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Post Operative Ileus | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Bood Prolactin Increased | Investigations | MedDRA Version 16.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
|
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D007267 |
| Injections |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |