Trial Condition(s):
Functional Gastrointestinal Disorders
Study to learn more about the stomach and intestine complaints of children aged from 3 to 14 years
Bayer Identifier:
20983
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Gastrointestinal Symptoms Profile (GIS) ScoreThe 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.Timeframe: Up to 1 week
- Global Assessment of the Efficacy by the PhysiciansTreatment success assessed by physiciansTimeframe: Up to 1 week
- Global Assessment of the Efficacy by the Children or Their ParentsTreatment success judged by children or their parentsTimeframe: Up to 1 week
- Lost Attendance daysThe number of lost attendance days kindergarten/schoolTimeframe: Up to 1 week
Secondary Outcome
- Global Assessment of the Tolerability by the PhysicianThe tolerability of Iberogast assessed by physicianTimeframe: Up to 1 week
- The number of subjects with adverse eventsThe number of subjects who had any adverse event during the studyTimeframe: Up to 1 week
Additional Information
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