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

NCT05389709 | Completed

• 1 other identifier: 21970
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia; Irritable Bowel Syndrome; Functional Dyspepsia

Keywords

Iberogast Advance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Descriptive analyses of patient characteristics data

  At baseline

• Descriptive analyses of patient symptoms profile

  At baseline

• Reason for using Iberogast Advance

  At baseline

• Long term usage during the previous 6 months

  At baseline

• Usual dosage applicated assessed weekly

  Up to 6 weeks

Study Arms (1)

Pharmacy based survey

Patients receive a questionnaire to fill out and return it the Contract Research Organization (CRO) or, alternatively to the pharmacy.

Drug: Iberogast (STW5-II, BAY98-7410)

Interventions

Iberogast (STW5-II, BAY98-7410) DRUG

Survey without any intervention assigned in the study.

Also known as: Iberogast® Advance

Pharmacy based survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

German patients who use Iberogast Advance for treatment of gastrointestinal complaints.

You may qualify if:

• 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

You may not qualify if:

• Patients with known hypersensitivity to any of the ingredients of Iberogast Advance
• Pregnant or lactating women

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Many Locations, Germany

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

iberogast

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: June 4, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)