Clinical trial NCT04059783: Study to Learn More About the Onset of Effect of Iberogast in Patients Suffering From Abnormal Stomach and Intestine Function
Official title: Non-interventional Study on the Onset of Effect of Iberogast in Patients With Functional or Motility-related Gastrointestinal Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-08-16
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients of at least 18 years were to be observed

Brief summary: Several studies have been done on the efficacy of the herbal medicine Iberogast. In this study researcher want to learn more about the time needed for Iberogast to start to work after the patient took the drug. This study plans to enroll 300 adult male and female patients suffering from disturbance of stomach and intestine normal function and treated by their doctor with Iberogast drops. Patients will be asked to document on a diary card the changes of symptom severity of the stomach and intestine complaints and the time needed for the symptoms to improve after drug intake. At the end of the study the treating doctor and the patients will be asked about the overall changes of symptoms. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected


Eligibility criteria: Inclusion criteria:

At the discretion of physician under the instructions of Rome III criteria concerning functional gastrointestinal symptoms as well as the summary of product characteristics of Iberogast

Exclusion criteria:

Therapeutic necessity

Primary outcomes:
measure: Change of GIS score from baseline up to 3 weeks after treatment
timeFrame: At baseline and up to 3 weeks post-treatment
measure: Global assessment by the physicians using a 4-point likert scale
timeFrame: Up to 3 weeks
measure: Global assessment by the patient using a 4-point likert scale
timeFrame: Up to 3 weeks
measure: Change of ratings of symptom severity on a 100-mm visual analogue scale (VAS) over time after intake of Iberogast
timeFrame: At baseline and up to 2 hours post-treatment on day 1
measure: Onset of improvement assessed by patient on day 1
timeFrame: On day 1
measure: Onset of improvement assessed by patient on day 2
timeFrame: On day 2
measure: Onset of improvement assessed by patient on day 3
timeFrame: On day 3
measure: Onset of improvement assessed by patient on day 4
timeFrame: On day 4
measure: Onset of improvement assessed by patient on day 5
timeFrame: On day 5
measure: Onset of improvement assessed by patient on day 6
timeFrame: On day 6
measure: Onset of improvement assessed by patient on day 7
timeFrame: On day 7
measure: Onset of improvement assessed by patient on day 8
timeFrame: On day 8
Secondary outcomes:
measure: The number of participants with adverse events
timeFrame: Up to 3 weeks
measure: The number of participants who discontinued from treatment
timeFrame: Up to 3 weeks
measure: The number of participants with the need of further treatment
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References: