WHO ICTRP trial
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in…
EUCTR2014-003511-11-SK · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2014-003511-11-SK |
|---|---|
| Public title | A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients with Type 2 Diabetes and also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients with Different Degrees of PEI |
| Scientific title | 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… |
| Primary sponsor | AstraZeneca AB |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Hungary;Slovakia;Poland;Latvia;Sweden |
| Conditions | Type 2 Diabetes MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic… |
| Interventions | Product Name: Epanova Product Code: Epanova Pharmaceutical Form: Capsule, soft INN or Proposed INN: NA Current Sponsor code: Omefas Other descriptive name: OMEGA-3 FATTY ACIDS Concentration unit: mg/g milligram(s)/gram Concentration type… |
| Registration date | Oct 12, 2014 |
| Target size | 300 |
| Secondary IDs | D5881C00006 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: