A Pharmacy-based Study to Learn More About How Well Iberogast Works, How it Affects the Body, How it is Used, and User Satisfaction in Patients With Functional and Motility-related (Stomach and Bowel Movement-related) Gastrointestinal Diseases, Including Irritable Bowel Syndrome

Pharmacy-based Study on the Effectiveness, Tolerability, Usage Behavior and User Satisfaction of Iberogast® in Functional and Motility-related Gastrointestinal Diseases, Preferably Irritable Bowel Syndrome.

Researchers want to learn more about the day-to-day use of Iberogast in people who have functional and motility-related gastrointestinal (stomach and bowel) diseases.

Functional and motility-related stomach and bowel diseases are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis is disturbed. Functional and motility related stomach and bowel diseases cause symptoms like heartburn, cramps and u 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.

In this study, the researchers want to learn more about Iberogast, a plant-based treatment. Iberogast is available to treat stomach and bowel diseases such as FD and IBS.

Earlier studies with Iberogast have shown how well it works and how it affects the body. But, little is known about the day-to-day use of Iberogast and how satisfied patients are who take it. So in this study, the researchers want to learn more about Iberogast including:

• how well it works in day-to-day use
• how it affects the body, also referred to as tolerability
• how it is used day-to-day
• how safe it is
• how satisfied patients are who take it

To answer these questions, the researchers will collect information from pharmacies in Germany. Patients who get Iberogast from these pharmacies to help treat their gastrointestinal disease will complete a questionnaire before, during and after taking Iberogast. The researchers will use the results from the questionnaires to learn more about:

• the disease details of the patients who are taking Iberogast
• the patients' symptoms while taking Iberogast
• if the patients' symptoms change after taking Iberogast
• how satisfied patients are with Iberogast
• if the patients had adverse events

An adverse event is any medical problem that a participant has during a study.

This study will include patients in Germany who:

• have functional stomach and bowel symptoms or disorders like FD or IBS
• take Iberogast to treat symptoms of their stomach and bowel disease
• are able to complete the questionnaire

There will be no required tests or visits with a study doctor in this study. No treatments will be given as part of this study. The researchers will review information collected from patients who have decided for their own or by recommendation of their doctors or pharmacist to take Iberogast. The researchers will collect the results from the patient questionnaires from November 2017 to March 2018.

Study Overview

• Status: Completed
• Conditions: Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia
• Intervention / Treatment: Drug: Iberogast (STW5, BAY98-7411)

• Study Type: Observational
• Enrollment (Actual): 843

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

German patients who used Iberogast for treatment of gastrointestinal complaints.

Description

Inclusion Criteria:

• Patients received a questionnaire, if all of the following applied:

  • Patients intent to use Iberogast® for the treatment of functional gastrointestinal symptoms (e.g. stomach pain, abdominal cramps, nausea, bloating, flatulence and heartburn) as well as defined functional dyspepsia (FD) and irritable bowel syndrome (IBS).
  • Patients suffered more from intestine-related complaints
  • Patients expressed their interest in participating in the study
  • Patients were willing and able to answer the questionnaire completely and plausibly

Exclusion Criteria:

• Patients did not receive a questionnaire, if

  • Patients did not currently use Iberogast® to treat gastrointestinal diseases such as irritable stomach and irritable bowel syndrome (medicine cabinet & travel medicine cabinet) or bought the product for someone else
  • Patients did not give a specific reason for treatment
  • Patients did not show interest in participating
  • Patients suffered exclusively from diarrhea and constipation
  • Patients suffered exclusively from heartburn.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pharmacy based survey; Patients received a questionnaire, which was filled out and returned to the Contract Research Organization (CRO) or, alternatively to the pharmacy.	Drug: Iberogast (STW5, BAY98-7411); Survey without any intervention assigned in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of symptom improvement as assessed by patients	Patients answered how quickly a significant improvement in their gastrointestinal symptoms was felt after taking Iberogast.	At baseline
Symptom improvement as assessed by patients.	Patients assessed the improvement in symptoms/concomitant complaints on an 5 -point Likert scale from 0=no improvement, 1=mild improvement, 2=moderate improvement, 3=good improvement, to 4=very good improvement.	7 days
Effectiveness of Iberogast in comparison to other treatments as assessed by patient.	Patients indicated the respective medication they used/ consumed earlier for their complaints on an 3 -point rating scale as "better", "same" and "poorer".	7 days
Number of participants with gastrointestinal complaints ,categorized by severity.	Patients assessed tolerability with Iberogast on 5-point Likert scale as "very good", "good", "medium", "poor", and "very poor''.	7 days
Patients´ usage behavior as assessed by patients.	Patients answered why Iberogast was chosen and what was the source of awareness of the product.	At baseline
Number of participants with adverse events.		7 days
Patients 'satisfaction as assessed by patients.	Patients assess their satisfaction with Iberogast on 5 point Likert scale as "very satisfied", "satisfied", "neither satisfied nor unsatisfied", "unsatisfied", and "very unsatisfied.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analyses of demographic data.	Age and sex.	At baseline
Percentage of patients consulted physician for examination to clarify gastrointestinal complaints.	Functional dyspepsia (FD) and irritable bowel syndrome (IBS) or both.	At baseline

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2017
• Primary Completion (ACTUAL): April 18, 2018
• Study Completion (ACTUAL): April 18, 2018

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (ACTUAL): August 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Irritable bowel syndrome; Functional dyspepsia; Iberogast; Stomach mucosal inflammation; Pharmacy based survey
• 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: 21971

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.clinicalstudydatarequest.com 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 Study sponsors 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