check_circleStudy Completed

Functional Gastrointestinal Disorders

Bayer Identifier:

20983

ClinicalTrials.gov Identifier:

NCT04029376

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to learn more about the stomach and intestine complaints of children aged from 3 to 14 years

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

3 - 14 Years
  • 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 summary

Enrollment Goal
1032
Trial Dates
April 2007 - October 2008
Phase
N/A
Could I Receive a placebo
No
Products
Iberogast (STW5, BAY98-7411)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 1 week
  • Global Assessment of the Efficacy by the Physicians
    Treatment success assessed by physicians
    date_rangeTime Frame:
    Up to 1 week
  • Global Assessment of the Efficacy by the Children or Their Parents
    Treatment success judged by children or their parents
    date_rangeTime Frame:
    Up to 1 week
  • Lost Attendance days
    The number of lost attendance days kindergarten/school
    date_rangeTime Frame:
    Up to 1 week

Secondary Outcome

  • Global Assessment of the Tolerability by the Physician
    The tolerability of Iberogast assessed by physician
    date_rangeTime Frame:
    Up to 1 week
  • The number of subjects with adverse events
    The number of subjects who had any adverse event during the study
    date_rangeTime Frame:
    Up to 1 week

Trial design

Non-Interventional Study of Children Aged from 3 to 14 Years Suffering from Functional Gastrointestinal Complaints Classified According to the Rome Criteria
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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