check_circleStudy Completed
Functional and motility related gastrointestinal disorders such as irritable bowel syndrome and functional dyspepsia
Bayer Identifier:infoA unique number for a trial given by Bayer.
21971
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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.
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
AllAge
3 - N/ATrial summary
Enrollment Goal info
843The overall number of participants needed for a trial.
Trial Dates info
November 2017 - April 2018Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
N/AA phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Iberogast (STW5, BAY98-7411)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | Many Locations | Many Locations, Germany |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Onset of symptom improvement as assessed by patientsPatients 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
OtherThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.