E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Predicted severe acute pancreatitis |
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E.1.1.1 | Medical condition in easily understood language |
Predicted severe acute pancreatitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 PLANCTON trial will investigate the effect of early intravenous omega-3 fatty acids on new onset organ failure and mortality in patients with predicted severe acute pancreatitis |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are individual components of the composite endpoint, severe complications (([infected] pancreas necrosis, sepsis, pneumonia or cholangitis), quality of life, costs effectiveness, number of (surgical, endoscopic or radiologic) interventions, length of hospital and ICU stay. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Predicted severe acute pancreatitis • ≥18 years old • First episode of acute pancreatitis • <24 hours after diagnosis of acute pancreatitis • <72 hours after onset of symptoms of acute pancreatitis • Able to read and/or understand the study procedures • Able to give informed consent (or their legal representatives)
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E.4 | Principal exclusion criteria |
• Intake of omega-3 fatty acids • Participation in another intervention study for acute pancreatitis • Organ failure on admission (Modified Marshall score >2) • Recurrent pancreatitis • Chronic pancreatitis o Defined by the MANNHEIM criteria • Known allergy to fish oil, seafood, soja or egg products • History or existing hyperlipidemia (laboratory proven triglycerides > 10.0 mmol/l) • History of (severe) liver failure o Impaired lipid metabolism may lead to accumulation of fatty acids in the blood, increasing risk of adverse events. o Based on coagulation Factor V level or INR > 3 (without anti-coagulation by vitamine K) • Ketoacidosis • Acute thrombo-embolic disease • Pregnancy or lactation • Recent (< 6 months) myocardial infarction or stroke • Known coagulations disorders (e.g. Factor V Leiden, thrombocytopenia, etc.) • Patient is classified as moribund or expected to die within 24hours o The intervention will not be able to affect this patient and is therefore useless to expose these patients.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is a composite endpoint of new onset of organ failure (organ failure not present at randomization) and mortality. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
from the moment of randomization untill 180 days afterwards |
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E.5.2 | Secondary end point(s) |
Secondary endpoints are individual components of the composite endpoint, severe complications (([infected] pancreas necrosis, sepsis, pneumonia or cholangitis), quality of life, costs effectiveness, number of (surgical, endoscopic or radiologic) interventions, length of hospital and ICU stay. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
from the moment of randomization untill 180 days afterwards |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Current clinical practice |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 15 |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |