A Pharmacy-based Observational Study to Learn More About Iberogast Advance in the Real-world Setting

Irritable Bowel Syndrome Clinical Trial

Official title:

Pharmacy-based Non-interventional Study (NIS) With Iberogast® Advance (STW 5 II).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05389709
• Other study ID #: 21970
• Status: Completed
• Start date: June 4, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: December 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study in which data from people with functional gastrointestinal disorders who decide on their own or by recommendation of their doctors or pharmacists to take Iberogast Advance are collected and studied. In observational studies, only observations are made without specified advice or interventions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult female or male subject aged = 18

• 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:

• Patients with known hypersensitivity to any of the ingredients of Iberogast Advance

• Pregnant or lactating women

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Functional Dyspepsia
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Iberogast (STW5-II, BAY98-7410)
Survey without any intervention assigned in the study.

Locations

Country	Name	City	State
Germany	Many Locations	Multiple Locations	Many Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single gastrointestinal symptoms intensity via a five point Likert scale assessed weekly.	Patients assessed intensity on 5 point Likert scale as 0=no symptom; 1=mild symptom; 2= moderate symptom; 3=strong symptom; 4= unbearable symptom.	Up to 6 weeks
Secondary	Descriptive analyses of patient characteristics data		At baseline
Secondary	Descriptive analyses of patient symptoms profile		At baseline
Secondary	Reason for using Iberogast Advance		At baseline
Secondary	Long term usage during the previous 6 months		At baseline
Secondary	Usual dosage applicated assessed weekly		Up to 6 weeks
Secondary	Onset of noticeable symptom relief after application of Iberogast Advance as assessed by patient weekly.		Up to 6 weeks
Secondary	Overall treatment effect of Iberogast Advance measured as course of gastrointestinal symptom intensity as assessed by patient		At week 6
Secondary	Change of symptoms after 6 weeks treatment/observation period via a five point Likert scale	Patients assessed intensity on 5 point Likert scale as 0=no symptom; 1=mild symptom; 2= moderate symptom; 3=strong symptom; 4= unbearable symptom.	Baseline to week 6
Secondary	Patients satisfaction as assessed by patients as assessed via a five point Likert scale.	Patients assessed intensity on 5 point Likert scale as 0=no symptom; 1=mild symptom; 2= moderate symptom; 3=strong symptom; 4= unbearable symptom.	At week 6
Secondary	Number of participants with gastrointestinal complaints ,categorized by severity.		At week 6
Secondary	Reason for early termination of Iberogast Advance		At week 6
Secondary	Tolerability as assessed by the patient	Patients assessed tolerability by using very good; Good; Moderate; Bad; Very bad; Missing values.	At week 6

External Links

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