Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional DyspepsiaNCT04993989
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
An observational study of Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia, run by Bayer at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia
- What is being tested?
- Iberogast (STW5, BAY98-7411)
- How many people
- 843 participants
- Where
- 1 siteGermany
- Study dates
- 16 Nov 2017to 18 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: German patients who used Iberogast for treatment of gastrointestinal complaints.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Iberogast (STW5, BAY98-7411)
- Keywords
- Iberogast, Functional dyspepsia, Irritable bowel syndrome, Stomach mucosal inflammation, Pharmacy based survey
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iberogast (STW5, BAY98-7411)Drug
Survey without any intervention assigned in the study.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacy based survey | Patients received a questionnaire, which was filled out and returned to the Contract Research Organization (CRO) or, alternatively to the pharmacy. Receives: Drug: Iberogast (STW5, BAY98-7411) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of symptom improvement as assessed by patients
Patients answered how quickly a significant improvement in their gastrointestinal symptoms was felt after taking Iberogast.
Measured: 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.
Measured: 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".
Measured: 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''.
Measured: 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.
Measured: At baseline
Number of participants with adverse events.
Measured: 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.
Measured: 7 days
Secondary outcomes (2)
Descriptive analyses of demographic data.
Age and sex.
Measured: At baseline
Percentage of patients consulted physician for examination to clarify gastrointestinal complaints.
Functional dyspepsia (FD) and irritable bowel syndrome (IBS) or both.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start16 Nov 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993989
- Sponsor's protocol ID
- 21971
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04993989
- Acronym / sponsor ID
- 21971
- Keywords
- Iberogast, Functional dyspepsia, Irritable bowel syndrome, Stomach mucosal inflammation, Pharmacy based survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacy based survey | – | Drug: Iberogast (STW5, BAY98-7411)Patients received a questionnaire, which was filled out and returned to the Contract Research Organization (CRO) or, alternatively to the pharmacy. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- German patients who used Iberogast for treatment of gastrointestinal complaints.
Key inclusion criteria (5 listed)
- Patients received a questionnaire, if all of the following applied:
Key exclusion criteria (6 listed)
- Patients did not receive a questionnaire, if
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iberogast (STW5, BAY98-7411)Survey without any intervention assigned in the study. | Drug | Pharmacy based survey |
Primary outcome
Onset of symptom improvement as assessed by patients
Time frame: At baseline
Patients answered how quickly a significant improvement in their gastrointestinal symptoms was felt after taking Iberogast.
Symptom improvement as assessed by patients.
Time frame: 7 days
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.
Effectiveness of Iberogast in comparison to other treatments as assessed by patient.
Time frame: 7 days
Patients indicated the respective medication they used/ consumed earlier for their complaints on an 3 -point rating scale as "better", "same" and "poorer".
Number of participants with gastrointestinal complaints ,categorized by severity.
Time frame: 7 days
Patients assessed tolerability with Iberogast on 5-point Likert scale as "very good", "good", "medium", "poor", and "very poor''.
Patients´ usage behavior as assessed by patients.
Time frame: At baseline
Patients answered why Iberogast was chosen and what was the source of awareness of the product.
Number of participants with adverse events.
Time frame: 7 days
Patients 'satisfaction as assessed by patients.
Time frame: 7 days
Patients assess their satisfaction with Iberogast on 5 point Likert scale as "very satisfied", "satisfied", "neither satisfied nor unsatisfied", "unsatisfied", and "very unsatisfied.
2 secondary outcomes
Descriptive analyses of demographic data.
Time frame: At baseline
Percentage of patients consulted physician for examination to clarify gastrointestinal complaints.
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of symptom improvement as assessed by patients (time frame: At baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.