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A study to provide information about people with gastroparesis from healthcare databases in Finland and Spain

IDENTIFIERS
Trial Protocol: TAK-906-5003
EUPAS: EUPAS37806
PURPOSE

The study will provide information about people with gastroparesis. The main aims are to estimate the number of new cases of gastroparesis during a specific time and to estimate the total number of cases of gastroparesis. Cases of gastroparesis will be found from records held in large healthcare databases, based on information on diagnoses, test results, and treatment for the condition. Children, teenagers, and adults will be included in the study.

Recruiting

Trial at a glance

What medical condition is being studied?   Gastroparesis
When is the trial being conducted?    - 
How long is participation in the trial?   The study will take place in Finland and Spain. The study duration will depend on when the complete information is available in each specific study database. The study will start 1 year after the complete information is available in each specific database. The study will end on the last date of available information.

Key requirements

Sex   
All
Age   
All
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Type:   Observational
Primary Outcome Measure(s):   
The primary outcome for the analyses of incidence and prevalence will be gastroparesis, as identified using a case definition based on information on diagnoses and other clinical records, records of conducted tests and test results, procedures, and recorded pharmacological and non-pharmacological treatment. [Time Frame: The study will start 1 year after the complete information is available in each specific database. The study will end on the last date of available information.]
Entry Criteria:
- This study will analyze information about boys, girls, men and women. - Must be part of the source population at any time during the study. The source population can be anyone in Spain or people in Finland with records in the Hospital Districts of Helsinki and Uusimaa, or North Savo. - Must have available information on sex and date of birth. - Cannot have gastrointestinal cancer, inflammatory bowel disease (IBD), or celiac disease. - Cannot have a negative test for delayed gastric emptying.