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Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years

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ClinicalTrials.gov Identifier: NCT04029376
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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. 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.

Condition or disease Intervention/treatment
Functional Gastrointestinal Disorders Drug: Iberogast®

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Study Type : Observational
Actual Enrollment : 1032 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study of Children Aged From 3 to 14 Years Suffering From Functional Gastrointestinal Complaints Classified According to the Rome Criteria
Actual Study Start Date : April 1, 2007
Actual Primary Completion Date : October 1, 2008
Actual Study Completion Date : October 1, 2008

Intervention Details:
  • Drug: Iberogast®
    The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar.


Primary Outcome Measures :
  1. 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.

  2. Global Assessment of the Efficacy by the Physicians [ Time Frame: Up to 1 week ]
    Treatment success assessed by physicians

  3. 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

  4. Lost Attendance days [ Time Frame: Up to 1 week ]
    The number of lost attendance days kindergarten/school


Secondary Outcome Measures :
  1. Global Assessment of the Tolerability by the Physician [ Time Frame: Up to 1 week ]
    The tolerability of Iberogast assessed by physician

  2. The number of subjects with adverse events [ Time Frame: Up to 1 week ]
    The number of subjects who had any adverse event during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female children aged between 3 and up to 14 years with Functional Gastrointestinal Complaints
Criteria
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029376


Locations
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Germany
Many locations
Multiple Locations, Germany
Sponsors and Collaborators
Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04029376     History of Changes
Other Study ID Numbers: 20983
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases