Functional Gastrointestinal DisordersNCT04029376
Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years
An observational study of Functional Gastrointestinal Disorders, run by Bayer at 1 site in Germany.
Trial summary
In this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the Rome criteria) and treated Iberogast. The Rome criteria have been developed by experts to support doctors to diagnose stomach and intestine disorders. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Iberogast®
- How many people
- 1,032 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2007to 1 Oct 2008
- 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 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Male and female children aged between 3 and up to 14 years with Functional Gastrointestinal Complaints
The selection of the children to be documented was the sole responsibility of the physician whereby the information of the Rome III criteria on functional gastrointestinal diseases in children as well as the prescribing information on Iberogast could be consulted as guideline. Only the therapeutic necessity was determining for the use of all medicines. The treating physicians received standardised information regarding the ailment picture (Rome III criteria) before the beginning of the study and during the investigator meetings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Interventional Study of Children Aged From 3 to 14 Years Suffering From Functional Gastrointestinal Complaints Classified According to the Rome Criteria
In this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the Rome criteria) and treated Iberogast. The Rome criteria have been developed by experts to support doctors to diagnose stomach and intestine disorders. This study will focus on children aged from 3 to 14 years in age treated by their doctor with the herbal drug Iberogast for their stomach and intestine complaints for one week. Researcher want to learn more about the efficacy of Iberogast by observing the changes of symptoms related to the stomach and intestine disorders. 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
- Iberogast®
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iberogast®Drug
The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptoms Profile (GIS) Score
The score was developed by Steigerwald Arzneimittelwerk GmbH in co-operation with a gastroenterological expert group and validated (Holtmann et al. 2004, Adam et al., 2005). It consists of 10 individual symptoms that were regarded as being typical for dyspepsia. They were evaluated based on a 5-stage Likert scale. The score was adapted to the special situation of children and adolescents with functional gastrointestinal disorders as part of the study concept. The change in the summary score during therapy serves as evaluation criterion for the efficacy of the therapeutic measure. The symptoms profile essentially involves all the symptoms of functional dyspepsia mentioned by the German Society for Gastrointestinal and Metabolic Diseases (DGVS) or international Rome criteria. Its usability was confirmed by the validation procedure.
Measured: Up to 1 week
Global Assessment of the Efficacy by the Physicians
Treatment success assessed by physicians
Measured: Up to 1 week
Global Assessment of the Efficacy by the Children or Their Parents
Treatment success judged by children or their parents
Measured: Up to 1 week
Lost Attendance days
The number of lost attendance days kindergarten/school
Measured: Up to 1 week
Secondary outcomes (2)
Global Assessment of the Tolerability by the Physician
The tolerability of Iberogast assessed by physician
Measured: Up to 1 week
The number of subjects with adverse events
The number of subjects who had any adverse event during the study
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Apr 2007
- Primary completion1 Oct 2008
- Study completion1 Oct 2008
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
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029376
- Sponsor's protocol ID
- 20983
- Status last verified
- Sep 2019
- First submitted
- 22 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 of Children Aged From 3 to 14 Years Suffering From Functional Gastrointestinal Complaints Classified According to the Rome Criteria
- ClinicalTrials.gov ID
- NCT04029376
- Acronym / sponsor ID
- 20983
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 1 Oct 2008 (actual)
- Study completion
- 1 Oct 2008 (actual)
- First posted
- 23 Jul 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.
In this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the Rome criteria) and treated Iberogast. The Rome criteria have been developed by experts to support doctors to diagnose stomach and intestine disorders. This study will focus on children aged from 3 to 14 years in age treated by their doctor with the herbal drug Iberogast for their stomach and intestine complaints for one week. Researcher want to learn more about the efficacy of Iberogast by observing the changes of symptoms related to the stomach and intestine disorders. 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
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male and female children aged between 3 and up to 14 years with Functional Gastrointestinal Complaints
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®The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar. | Drug | – |
Primary outcome
Gastrointestinal Symptoms Profile (GIS) Score
Time frame: Up to 1 week
The score was developed by Steigerwald Arzneimittelwerk GmbH in co-operation with a gastroenterological expert group and validated (Holtmann et al. 2004, Adam et al., 2005). It consists of 10 individual symptoms that were regarded as being typical for dyspepsia. They were evaluated based on a 5-stage Likert scale. The score was adapted to the special situation of children and adolescents with functional gastrointestinal disorders as part of the study concept. The change in the summary score during therapy serves as evaluation criterion for the efficacy of the therapeutic measure. The symptoms profile essentially involves all the symptoms of functional dyspepsia mentioned by the German Society for Gastrointestinal and Metabolic Diseases (DGVS) or international Rome criteria. Its usability was confirmed by the validation procedure.
Global Assessment of the Efficacy by the Physicians
Time frame: Up to 1 week
Treatment success assessed by physicians
Global Assessment of the Efficacy by the Children or Their Parents
Time frame: Up to 1 week
Treatment success judged by children or their parents
Lost Attendance days
Time frame: Up to 1 week
The number of lost attendance days kindergarten/school
2 secondary outcomes
Global Assessment of the Tolerability by the Physician
Time frame: Up to 1 week
The number of subjects with adverse events
Time frame: Up to 1 week
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?
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?
Gastrointestinal Symptoms Profile (GIS) Score (time frame: Up to 1 week). The study lists 4 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.