A Pharmacy-based Observational Study to Learn More About Iberogast Advance in the Real-world Setting
NCT ID: NCT05389709
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
184 participants
OBSERVATIONAL
2022-06-04
2023-05-11
Brief Summary
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Functional stomach and bowel (or gastrointestinal) disorders are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis, is disturbed. Functional stomach and bowel disorders cause symptoms like heartburn, cramps and pain of the upper and middle part of the belly, also known as functional dyspepsia (FD) and irritable bowel syndrome (IBS). IBS affects predominantly the lower digestive system and causes symptoms like pain of the belly, cramps, bloating, diarrhea, and constipation.
Iberogast Advance is already available in German pharmacies without prescription for patients with gastrointestinal disorders such as FD and IBS. It contains herb extracts that work against inflammation, are calming, and protect the mucosa (innermost layer of the gastrointestinal tract). Earlier controlled studies with Iberogast Advance have shown how well it works and how it affects the body. Since Iberogast Advance is only available since October 2020, there is no information on its use in the real-world setting yet.
Therefore, the study researchers want to collect data on the use of Iberogast Advance in the real-world setting.
To do this, people with long-term and repeated functional gastrointestinal symptoms who purchase Iberogast Advance from participating pharmacies across Germany will be asked to fill out a questionnaire optionally covering 6 weeks of treatment. The participants will take Iberogast Advance as recommended in the product information.
The main purpose of this study is to see how well Iberogast Advance works and is perceived in the real-world setting. Participants will record how they experience a change of their gastrointestinal symptoms (assessed single-symptom-based) from start and during 6 weeks of treatment. Researchers will then compare the differences and analyze treatment effects.
The researchers will additionally collect information on usage behavior, characteristics of the patients, their symptoms, tolerability and their satisfaction with Iberogast Advance.
There will be no required tests or visits with a study doctor in this study. The researchers will collect the results of the patient questionnaires from Jun 2022 to January 2023.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pharmacy based survey
Patients receive a questionnaire to fill out and return it the Contract Research Organization (CRO) or, alternatively to the pharmacy.
Iberogast (STW5-II, BAY98-7410)
Survey without any intervention assigned in the study.
Interventions
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Iberogast (STW5-II, BAY98-7410)
Survey without any intervention assigned in the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Decision to initiate treatment with Iberogast Advance was made as per pharmacist's routine recommendation practice/by the subject
* Subject purchases Iberogast Advance for his own use
* Not pregnant or lactating
* Not hypersensitive to any of the ingredients of Iberogast Advance
Exclusion Criteria
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Many Locations
Multiple Locations, Many Locations, Germany
Countries
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Related Links
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Other Identifiers
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21970
Identifier Type: -
Identifier Source: org_study_id