Functional Gastrointestinal DisordersNCT04059783
Study to Learn More About the Onset of Effect of Iberogast in Patients Suffering From Abnormal Stomach and Intestine Function
An observational study of Functional Gastrointestinal Disorders, run by Bayer at 1 site in Germany.
Trial summary
Several studies have been done on the efficacy of the herbal medicine Iberogast. In this study researcher want to learn more about the time needed for Iberogast to start to work after the patient took the drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- STW5 (Iberogast®, BAY98-7411)
- Type of treatment
- Pill or oral medicine
- How many people
- 272 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jun 2008to 20 Feb 2011
- 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: Male or female patients of at least 18 years were to be observed
Who may be able to join
- At the discretion of physician under the instructions of Rome III criteria concerning functional gastrointestinal symptoms as well as the summary of product characteristics of Iberogast
Who cannot join
- Therapeutic necessity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study on the Onset of Effect of Iberogast in Patients With Functional or Motility-related Gastrointestinal Diseases
Several studies have been done on the efficacy of the herbal medicine Iberogast. In this study researcher want to learn more about the time needed for Iberogast to start to work after the patient took the drug. This study plans to enroll 300 adult male and female patients suffering from disturbance of stomach and intestine normal function and treated by their doctor with Iberogast drops. Patients will be asked to document on a diary card the changes of symptom severity of the stomach and intestine complaints and the time needed for the symptoms to improve after drug intake. At the end of the study the treating doctor and the patients will be asked about the overall changes of symptoms. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- STW5 (Iberogast®, BAY98-7411)
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STW5 (Iberogast®, BAY98-7411)Drug
The medication was applied 3 x 20 drops per day orally, before or at meals with some liquid, ideally three weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of GIS score from baseline up to 3 weeks after treatment
Gastrointestinal System Profile (GIS) includes 5 scores: 0=Not available, 1=Slight, 2=Moderate, 3=Severe, 4=Very severe
Measured: At baseline and up to 3 weeks post-treatment
Global assessment by the physicians using a 4-point likert scale
Therapeutic success assessed by physicians. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms
Measured: Up to 3 weeks
Global assessment by the patient using a 4-point likert scale
Therapeutic success assessed by patient. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms
Measured: Up to 3 weeks
Change of ratings of symptom severity on a 100-mm visual analogue scale (VAS) over time after intake of Iberogast
Visual Analogue Scale to evaluate the general severity of symptoms. It is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no symptoms) to 100 mm (severe symptoms).
Measured: At baseline and up to 2 hours post-treatment on day 1
Onset of improvement assessed by patient on day 1
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 1
Measured: On day 1
Onset of improvement assessed by patient on day 2
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 2
Measured: On day 2
Onset of improvement assessed by patient on day 3
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 3
Measured: On day 3
Onset of improvement assessed by patient on day 4
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 4
Measured: On day 4
Onset of improvement assessed by patient on day 5
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 5
Measured: On day 5
Onset of improvement assessed by patient on day 6
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 6
Measured: On day 6
Onset of improvement assessed by patient on day 7
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 7
Measured: On day 7
Onset of improvement assessed by patient on day 8
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 8
Measured: On day 8
Secondary outcomes (3)
The number of participants with adverse events
Participants who had adverse events during the study
Measured: Up to 3 weeks
The number of participants who discontinued from treatment
Participants who discontinued from study treatment
Measured: Up to 3 weeks
The number of participants with the need of further treatment
Participants who needed further treatment
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start17 Jun 2008
- Primary completion27 Apr 2010
- Study completion20 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies 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
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059783
- Sponsor's protocol ID
- 20984
- Status last verified
- Sep 2019
- First submitted
- 12 Jul 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will 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 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on the Onset of Effect of Iberogast in Patients With Functional or Motility-related Gastrointestinal Diseases
- ClinicalTrials.gov ID
- NCT04059783
- Acronym / sponsor ID
- 20984
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2008 (actual)
- Primary completion
- 27 Apr 2010 (actual)
- Study completion
- 20 Feb 2011 (actual)
- First posted
- 16 Aug 2019 (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.
Several studies have been done on the efficacy of the herbal medicine Iberogast. In this study researcher want to learn more about the time needed for Iberogast to start to work after the patient took the drug. This study plans to enroll 300 adult male and female patients suffering from disturbance of stomach and intestine normal function and treated by their doctor with Iberogast drops. Patients will be asked to document on a diary card the changes of symptom severity of the stomach and intestine complaints and the time needed for the symptoms to improve after drug intake. At the end of the study the treating doctor and the patients will be asked about the overall changes of symptoms. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients of at least 18 years were to be observed
Key inclusion criteria (1 listed)
- At the discretion of physician under the instructions of Rome III criteria concerning functional gastrointestinal symptoms as well as the summary of product characteristics of Iberogast
Key exclusion criteria (1 listed)
- Therapeutic necessity
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 |
|---|---|---|
| STW5 (Iberogast®, BAY98-7411)The medication was applied 3 x 20 drops per day orally, before or at meals with some liquid, ideally three weeks | Drug | – |
Primary outcome
Change of GIS score from baseline up to 3 weeks after treatment
Time frame: At baseline and up to 3 weeks post-treatment
Gastrointestinal System Profile (GIS) includes 5 scores: 0=Not available, 1=Slight, 2=Moderate, 3=Severe, 4=Very severe
Global assessment by the physicians using a 4-point likert scale
Time frame: Up to 3 weeks
Therapeutic success assessed by physicians. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms
Global assessment by the patient using a 4-point likert scale
Time frame: Up to 3 weeks
Therapeutic success assessed by patient. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms
Change of ratings of symptom severity on a 100-mm visual analogue scale (VAS) over time after intake of Iberogast
Time frame: At baseline and up to 2 hours post-treatment on day 1
Visual Analogue Scale to evaluate the general severity of symptoms. It is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no symptoms) to 100 mm (severe symptoms).
Onset of improvement assessed by patient on day 1
Time frame: On day 1
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 1
Onset of improvement assessed by patient on day 2
Time frame: On day 2
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 2
Onset of improvement assessed by patient on day 3
Time frame: On day 3
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 3
Onset of improvement assessed by patient on day 4
Time frame: On day 4
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 4
Onset of improvement assessed by patient on day 5
Time frame: On day 5
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 5
Onset of improvement assessed by patient on day 6
Time frame: On day 6
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 6
Onset of improvement assessed by patient on day 7
Time frame: On day 7
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 7
Onset of improvement assessed by patient on day 8
Time frame: On day 8
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 8
3 secondary outcomes
The number of participants with adverse events
Time frame: Up to 3 weeks
The number of participants who discontinued from treatment
Time frame: Up to 3 weeks
The number of participants with the need of further treatment
Time frame: Up to 3 weeks
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 19 Sep 2019.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will 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.
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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, 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 1 inclusion and 1 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 19 Sep 2019. 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?
Change of GIS score from baseline up to 3 weeks after treatment (time frame: At baseline and up to 3 weeks post-treatment). The study lists 12 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 19 Sep 2019.