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A Two-part, Open-label, Randomised, Crossover, Multicentre, Phase II Study to Investigate the Presence of Pancreatic Exocrine Insufficiency (PEI) in Patients with Type 2 Diabetes Mellitus, and to Investigate the Pharmacokinetics of EPANOVA and OMACOR Following a Single Oral Dose in Patients with Different Degrees of PEI

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Trial Profile

A Two-part, Open-label, Randomised, Crossover, Multicentre, Phase II Study to Investigate the Presence of Pancreatic Exocrine Insufficiency (PEI) in Patients with Type 2 Diabetes Mellitus, and to Investigate the Pharmacokinetics of EPANOVA and OMACOR Following a Single Oral Dose in Patients with Different Degrees of PEI

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Omega-3 carboxylic acids (Primary) ; Omega-3-acid ethyl esters
  • Indications Hypertriglyceridaemia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Acronyms PRECISE
  • Sponsors AstraZeneca

Most Recent Events

  • 09 May 2017 Results assessing association between faecal elastase-1 concentrations and gastrointestinal symptoms, plasma nutritional markers, and uptake of Epanova versus Omacor, presented at the Digestive Disease Week 2017.
  • 01 Dec 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
  • 21 Sep 2015 Planned End Date changed from 1 Oct 2015 to 1 Nov 2015, as reported by ClinicalTrials.gov record.

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