E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nausea and vomiting in the home (after discharge) after day-case surgery under general anesthesia- |
Illamående och kräkning efter hemgång vid dagkirurgi. |
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E.1.1.1 | Medical condition in easily understood language |
Nausea and vomiting in the home (after discharge) after day-case surgery under general anesthesia- |
Illamående och kräkning efter hemgång (i hemmet) vid dagkirurgi. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10028817 |
E.1.2 | Term | Nausea and vomiting symptoms |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036285 |
E.1.2 | Term | Postoperative nausea |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036901 |
E.1.2 | Term | Prophylaxis against postoperative nausea and vomiting |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054182 |
E.1.2 | Term | Perioperative nausea and vomiting prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028818 |
E.1.2 | Term | Nausea postoperative |
E.1.2 | System Organ Class | 100000004863 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate if palonosetron (com-pared to placebo) can reduce the incidence of postdischarge nausea and vomiting (PDNV) in patients with high risk for PDNV. In the high-risk group incidences of 40-50% are reported and a reduction in PDNV of 50% during the first 48 hours is clinically relevant.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: -Incidences of PDNV in the high risk group. Incidences of adverse reactions related to palonosetron (headache, constipation, dizzyness) - Incidence of PDNV in a low-risk group of patients (those who are not randomized). - Safety evaluations
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Male or female, >=18 years of age, who has given written consent for his/her participation to the study 2) Women of Childbearing Capacity (WOCBC) only if pregnancy test is negative or if the woman is using effective contraception methods. Acceptable meth-ods are such as oral contraceptives, contraceptive patches, contraceptive implant, vaginal contracep-tive, double-barrier methods (for example, condom and spermicide), intrauterine device (IUD), hormo-nal IUD and abstinence. 3) Scheduled for surgery under general anesthesia and planned to be discharged from the hospital the same day as surgery. 4) Able to understand and cooperative with the study protocol. 5) ASA-class I-II
To enter the randomization arm: 6) POstoperative PDNV-score >=3
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E.4 | Principal exclusion criteria |
1) Documented allergy or intolerance to study drugs 2) Severe psychiatric condition or other reasons that jeopardize compliance with follow up. 3) On fertile females, pregnancy assessed by anamnesis and pregnancy test. 4) Breast-feeding females 5) Intestinal obstruction, accessed by anamnesis or clinical findings. 6) Concomitant treatment with SSRI or SNRI
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E.5 End points |
E.5.1 | Primary end point(s) |
Complete response defined as no nausea or no vomiting or no rescue anti-emetics from discharge to the postop day 2. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
With questionnaires once daily until the evening on the second day after the procedure. |
På den andra dagens kväll efter operation |
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E.5.2 | Secondary end point(s) |
periods until postop day 3 - Need for rescue medications. - Adverse Events - Headache - Constipation - Visual disturbances - Re-admissions
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
With questionnaires once daily until the evening on the third day after the procedure.
A review of the patients chart at 28 days after the procedure. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last chart review (28 days after procedure) of the 160th patient entering the randomization part of the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |