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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

Tracking Information
First Submitted Date July 22, 2019
First Posted Date July 23, 2019
Last Update Posted Date September 19, 2019
Actual Study Start Date April 1, 2007
Actual Primary Completion Date October 1, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04029376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 22, 2019)
  • Global Assessment of the Tolerability by the Physician [ Time Frame: Up to 1 week ]
    The tolerability of Iberogast assessed by physician
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years
Official Title Non-Interventional Study of Children Aged From 3 to 14 Years Suffering From Functional Gastrointestinal Complaints Classified According to the Rome Criteria
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Male and female children aged between 3 and up to 14 years with Functional Gastrointestinal Complaints
Condition Functional Gastrointestinal Disorders
Intervention Drug: Iberogast®
The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 22, 2019)
1032
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2008
Actual Primary Completion Date October 1, 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04029376
Other Study ID Numbers 20983
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators Not Provided
PRS Account Bayer
Verification Date September 2019