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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 | IV APD421 single dose |
|
| Placebo | Placebo Comparator | IV placebo single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD421 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (no Emesis, Significant Nausea or Rescue Medication) | The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%. | 24 hours after end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (no Emesis or Rescue Medication) | 24 hrs after end of surgery | |
| Total Response (no Emesis, Nausea or Rescue Medication) | 24 hrs after end of surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Diemunsch, MD | Hôpital de Hautepierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Hautepierre | Strasbourg | France | ||||
| University Hospitals of Würzburg |
Of the 368 patients enrolled in the study, 21 patients were not randomised and not dosed. Of these, 3 withdrew their consent, 5 did not comply with the protocol procedures and 13 were not dosed for other unspecified reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | APD421 | APD421 (amisulpride), at 5 mg given by single intravenous (IV) administration, by slow push over one to two minutes, at induction of anaesthesia. |
| FG001 | Placebo | Matching placebo, given by single IV administration, by slow push over one minute at the induction of anaesthesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | APD421 | APD421 (amisulpride), at 5 mg given by single intravenous (IV) administration, by slow push over one to two minutes, at induction of anaesthesia. |
| BG001 | Placebo | Matching placebo, given by single IV administration, by slow push over one minute at the induction of anaesthesia. |
| 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 | Complete Response (no Emesis, Significant Nausea or Rescue Medication) | The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%. | Posted | Count of Participants | Participants | 24 hours after end of surgery |
|
Any AE that is serious occurring during the course of the study, irrespective of the treatment received by the subject must be reported to the pharmacovigilance provider within 24hours of it's recognition
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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 at 5mg | APD421 at 5mg given by single intravenous (IV) administration, by slow push over one to two minutes at induction of anaesthesia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomic Leak | Injury, poisoning and procedural complications | MedDRA v16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA v16.0 | Non-systematic Assessment |
There are no limitations and caveats with this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gabriel Fox | Acacia Pharma | 01223875130 | 149 | 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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|
| Incidence of Emesis (Vomiting/Retching) |
An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery |
| 24 hours after end of surgeryry |
| Incidence of Nausea | Count of patients experiencing an episode of nausea scored ≥ 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery | 24 hours after end of surgery |
| Incidence of Significant Nausea | Count of participants with nausea score ≥ 4 on 0-10 verbal response scale | 24 hours after end of surgery |
| Use of Rescue Medication | 24 hours after end of surgery |
| Würzburg |
| Germany |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Complete Response (no Emesis or Rescue Medication) | Posted | Count of Participants | Participants | 24 hrs after end of surgery |
|
|
|
|
| Secondary | Total Response (no Emesis, Nausea or Rescue Medication) | mITT | Posted | Count of Participants | Participants | 24 hrs after end of surgery |
|
|
|
|
| Secondary | Incidence of Emesis (Vomiting/Retching) | An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery | Posted | Count of Participants | Participants | 24 hours after end of surgeryry |
|
|
|
|
| Secondary | Incidence of Nausea | Count of patients experiencing an episode of nausea scored ≥ 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery | mITT | Posted | Count of Participants | Participants | 24 hours after end of surgery |
|
|
|
|
| Secondary | Incidence of Significant Nausea | Count of participants with nausea score ≥ 4 on 0-10 verbal response scale | Posted | Count of Participants | Participants | 24 hours after end of surgery |
|
|
|
|
| Secondary | Use of Rescue Medication | Posted | Count of Participants | Participants | 24 hours after end of surgery |
|
|
|
|
| 0 |
| 169 |
| 3 |
| 169 |
| 91 |
| 169 |
| EG001 | Placebo | APD421 Placebo given by single IV administration by slow push over one minute at induction of anaesthesia. | 0 | 178 | 4 | 178 | 178 | 178 |
| Gastrointestinal Stoma Complication | Injury, poisoning and procedural complications | MedDRA v16.0 | Non-systematic Assessment |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA v16.0 | Non-systematic Assessment |
|
| Portal Vein Thrombosis | Hepatobiliary disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Blood Prolactin Increased | Investigations | MedDRA v16.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDRA v16.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v16.0 | Non-systematic Assessment |
|
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |