check_circleStudy Completed

Functional and motility related gastrointestinal disorders such as irritable bowel syndrome and functional dyspepsia

Bayer Identifier:

21971

ClinicalTrials.gov Identifier:

NCT04993989

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

3 - N/A
  • - 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
  • - 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.

Trial summary

Enrollment Goal
843
Trial Dates
November 2017 - April 2018
Phase
N/A
Could I Receive a placebo
No
Products
Iberogast (STW5, BAY98-7411)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Germany

Primary Outcome

  • Onset of symptom improvement as assessed by patients
    Patients answered how quickly a significant improvement in their gastrointestinal symptoms was felt after taking Iberogast.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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”.
    date_rangeTime Frame:
    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''.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    At baseline
  • Number of participants with adverse events.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    7 days

Secondary Outcome

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

Trial design

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.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Study_Synopsis-21971.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (2.0), Protocol (0.2), Results(0.1)