Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amicus CD LLC | UNKNOWN |
| Premier Research | OTHER |
Not provided
Not provided
Not provided
Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting
Randomized, double-blind, Phase 2/3 study of IV amisulpride as prevention of post-operative nausea and vomiting in pediatric patients
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone | Experimental | Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone |
|
| Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone | Experimental | Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amisulpride Injection | Drug | Dose finding treatment for continuation to phase 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Complete Response | Defined as no vomiting/retching (absence of PONV) and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery. Subjects will be questioned and assessed. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of post-operative vomiting/retching | Subjects considered able to understand and provide a meaningful response should be asked if they have nausea ("feel sick" or other equivalent words) at the following times after completion of surgery (wound closure), unless an episode of PONV or discharge of the subject from the site has already occurred prior to the time point: 1 hour, 2 hours, 6 hours and 24 hours or when they first vomit, retch or receive rescue medication. In subjects aged ≥ 6 years, at the above time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kumar Belani, MD | University of Minnesota Masonic Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States | ||
| Emory Healthcare - Emory University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dexamethasone | Drug | Standard of care treatment |
|
|
| 1 Day |
| Use of rescue medication | Document use of rescue medication. | 1 Day |
| Occurrence and severity of post-operative nausea | An episode of nausea should be recorded any time that a subject spontaneously complains of nausea (including a request for rescue medication due to nausea). Subjects considered able to understand and provide a meaningful response should be asked if they have nausea ("feel sick" or other equivalent words) at the following times after completion of surgery (wound closure), unless an episode of PONV or discharge of the subject from the site has already occurred prior to the time point: 1 hour, 2 hours, 6 hours and 24 hours or when they first vomit, retch or receive rescue medication. In subjects aged ≥ 6 years, at the above time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale. | 1 Day |
| Time to emergence of PONV | Observe for, question and document emergence of vomiting/retching and nausea. In subjects aged ≥ 6 years, at specified time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale. | 1 Day |
| Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually | Observe for emergence of vomiting/retching, determine significance of nausea, and note rescue medication, individually. | 1 Day |
| Different variables during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h) | Subjects considered able to understand and provide a meaningful response should be asked if they have nausea ("feel sick" or other equivalent words) at the following times after completion of surgery (wound closure), unless an episode of PONV or discharge of the subject from the site has already occurred prior to the time point: 1 hour, 2 hours, 6 hours and 24 hours or when they first vomit, retch or receive rescue medication. In subjects aged ≥ 6 years, at the above time points and for any spontaneously reported nausea episode, nausea severity should be scored using the validated 6-point Baxter Retching Faces (BARF) scale. | 1 Day |
| The above variables in the sub-groups of patients who did and did not receive opioid analgesia | Concomitant medications will be reviewed. | 1 Day |
| Safety: The nature and frequency of adverse events and laboratory and electrocardiography (ECG) abnormalities | Adverse events, laboratory and ECG abnormalities will be noted. Blood samples should be drawn at screening (unless recent pre-existing results are available) and again post-operatively, as soon as practically possible after the patient's entry to the post-anesthesia care unit, recovery room or equivalent, and in any event within 1 hour after the end of surgery. Twelve-lead ECGs will be collected at screening. An ECG already taken as part of medical care within the period of 2 weeks prior to screening may be used to determine eligibility and to provide baseline ECG data. In the peri-/post-operative period, continuous Holter monitoring of the ECG will be performed, from at least 10 minutes prior until at least 2 hours after the start of administration of amisulpride study medication. | 7 Days |
| Key pharmacokinetics parameter - Peak Plasma Concentration | Plasma samples will be drawn as required at specified timepoints to determine the PK profile of peak plasma concentration of amisulpride in subjects. | 1 Day |
| Key pharmacokinetics parameter - Total Exposure | Plasma samples will be drawn as required at specified timepoints to determine the PK profile of total exposure of amisulpride in subjects. | 1 Day |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55455 | United States |
| The Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| McGill University Health Centre - The Montréal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| HCL - Hôpital Mère Enfant | Bron | 69677 | France |
| CHU Strasbourg - Hopital Hautepierre | Strasbourg | 67200 | France |
| Universitätsklinikum Würzburg | Würzburg | Bavaria | 97080 | Germany |
| Ambulantes Operieren Marburg | Marburg | Hesse | 35039 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Marburg | Hesse | 35043 | Germany |
| Universitaetsklinikum Bonn - Klinik für Anaesthesiologie & Operative Intensivmedizin | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Helios Klinikum Aue | Aue | 08280 | Germany |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided