Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional DyspepsiaNCT05389709
A Pharmacy-based Observational Study to Learn More About Iberogast Advance in the Real-world Setting
An observational study of Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia and Irritable Bowel Syndrome, run by Bayer at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia, Irritable Bowel Syndrome, Functional Dyspepsia
- What is being tested?
- Iberogast (STW5-II, BAY98-7410)
- How many people
- 184 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jun 2022to 11 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: German patients who use Iberogast Advance for treatment of gastrointestinal complaints.
Who may be able to join
- 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
Who cannot join
- Patients with known hypersensitivity to any of the ingredients of Iberogast Advance
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia, Irritable Bowel Syndrome, Functional Dyspepsia
- Being tested
- Iberogast (STW5-II, BAY98-7410)
- Keywords
- Iberogast Advance
- 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-II, BAY98-7410)Drug
Also called Iberogast® Advance
Survey without any intervention assigned in the study.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacy based survey | Patients receive a questionnaire to fill out and return it the Contract Research Organization (CRO) or, alternatively to the pharmacy. Receives: Drug: Iberogast (STW5-II, BAY98-7410) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
Secondary outcomes (12)
Descriptive analyses of patient characteristics data
Measured: At baseline
Descriptive analyses of patient symptoms profile
Measured: At baseline
Reason for using Iberogast Advance
Measured: At baseline
Long term usage during the previous 6 months
Measured: At baseline
Usual dosage applicated assessed weekly
Measured: Up to 6 weeks
Onset of noticeable symptom relief after application of Iberogast Advance as assessed by patient weekly.
Measured: Up to 6 weeks
Overall treatment effect of Iberogast Advance measured as course of gastrointestinal symptom intensity as assessed by patient
Measured: 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.
Measured: 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.
Measured: At week 6
Number of participants with gastrointestinal complaints ,categorized by severity.
Measured: At week 6
Reason for early termination of Iberogast Advance
Measured: At week 6
Tolerability as assessed by the patient
Patients assessed tolerability by using very good; Good; Moderate; Bad; Very bad; Missing values.
Measured: At week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start4 Jun 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389709
- Sponsor's protocol ID
- 21970
- Status last verified
- Dec 2023
- First submitted
- 20 May 2022
- Last updated
- 26 Dec 2023
- 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.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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacy-based Non-interventional Study (NIS) With Iberogast® Advance (STW 5 II).
- ClinicalTrials.gov ID
- NCT05389709
- Acronym / sponsor ID
- 21970
- Conditions
- Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia, Irritable Bowel Syndrome, Functional Dyspepsia
- Keywords
- Iberogast Advance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 25 May 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacy based survey | – | Drug: Iberogast (STW5-II, BAY98-7410)Patients receive a questionnaire to fill out and return it the Contract Research Organization (CRO) or, alternatively to the pharmacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- German patients who use Iberogast Advance for treatment of gastrointestinal complaints.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with known hypersensitivity to any of the ingredients of Iberogast Advance
- Pregnant or lactating women
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-II, BAY98-7410)Also: Iberogast® AdvanceSurvey without any intervention assigned in the study. | Drug | Pharmacy based survey |
Primary outcome
Single gastrointestinal symptoms intensity via a five point Likert scale assessed weekly.
Time frame: Up to 6 weeks
Patients assessed intensity on 5 point Likert scale as 0=no symptom; 1=mild symptom; 2= moderate symptom; 3=strong symptom; 4= unbearable symptom.
12 secondary outcomes
Descriptive analyses of patient characteristics data
Time frame: At baseline
Descriptive analyses of patient symptoms profile
Time frame: At baseline
Reason for using Iberogast Advance
Time frame: At baseline
Long term usage during the previous 6 months
Time frame: At baseline
Usual dosage applicated assessed weekly
Time frame: Up to 6 weeks
Onset of noticeable symptom relief after application of Iberogast Advance as assessed by patient weekly.
Time frame: Up to 6 weeks
Overall treatment effect of Iberogast Advance measured as course of gastrointestinal symptom intensity as assessed by patient
Time frame: At week 6
Change of symptoms after 6 weeks treatment/observation period via a five point Likert scale
Time frame: Baseline to week 6
Patients satisfaction as assessed by patients as assessed via a five point Likert scale.
Time frame: At week 6
Number of participants with gastrointestinal complaints ,categorized by severity.
Time frame: At week 6
Reason for early termination of Iberogast Advance
Time frame: At week 6
Tolerability as assessed by the patient
Time frame: At week 6
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 26 Dec 2023.
- 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.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.
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 Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia and Irritable Bowel Syndrome, 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 2 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 26 Dec 2023. 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?
Single gastrointestinal symptoms intensity via a five point Likert scale assessed weekly. (time frame: Up to 6 weeks). 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 26 Dec 2023.