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

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

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Irritable Bowel Syndrome; Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia
• Intervention / Treatment: Drug: Iberogast (STW5-II, BAY98-7410)

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Germany
  • Many Locations
    • Multiple Locations, Many Locations, Germany
      • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Survey without any intervention assigned in the study.; Other Names: Iberogast® Advance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Onset of noticeable symptom relief after application of Iberogast Advance as assessed by patient weekly.		Up to 6 weeks
Overall treatment effect of Iberogast Advance measured as course of gastrointestinal symptom intensity as assessed by patient		At week 6
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
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
Number of participants with gastrointestinal complaints ,categorized by severity.		At week 6
Reason for early termination of Iberogast Advance		At week 6
Tolerability as assessed by the patient	Patients assessed tolerability by using very good; Good; Moderate; Bad; Very bad; Missing values.	At week 6

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2022
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Iberogast Advance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Dyspepsia; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 21970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No