Study Completed

Functional Gastrointestinal Disorders,

Bayer Identifier:

20984

ClinicalTrials.gov Identifier:

NCT04059783

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to learn more about the onset of effect of Iberogast in patients suffering from abnormal stomach and intestine function

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal

272

Trial Dates

June 2008 - February 2011

Phase

N/A

Could I Receive a placebo

Products

Iberogast (STW5, BAY98-7411)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many locations	Many locations, Germany

Primary Outcome

Change of GIS score from baseline up to 3 weeks after treatment
Gastrointestinal System Profile (GIS) includes 5 scores: 0=Not available, 1=Slight, 2=Moderate, 3=Severe, 4=Very severe
Time Frame:
At baseline and up to 3 weeks post-treatment
Global assessment by the physicians using a 4-point likert scale
Therapeutic success assessed by physicians. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms
Time Frame:
Up to 3 weeks
Global assessment by the patient using a 4-point likert scale
Therapeutic success assessed by patient. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms
Time Frame:
Up to 3 weeks
Change of ratings of symptom severity on a 100-mm visual analogue scale (VAS) over time after intake of Iberogast
Visual Analogue Scale to evaluate the general severity of symptoms. It is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no symptoms) to 100 mm (severe symptoms).
Time Frame:
At baseline and up to 2 hours post-treatment on day 1
Onset of improvement assessed by patient on day 1
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 1
Time Frame:
On day 1
Onset of improvement assessed by patient on day 2
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 2
Time Frame:
On day 2
Onset of improvement assessed by patient on day 3
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 3
Time Frame:
On day 3
Onset of improvement assessed by patient on day 4
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 4
Time Frame:
On day 4
Onset of improvement assessed by patient on day 5
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 5
Time Frame:
On day 5
Onset of improvement assessed by patient on day 6
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 6
Time Frame:
On day 6
Onset of improvement assessed by patient on day 7
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 7
Time Frame:
On day 7
Onset of improvement assessed by patient on day 8
The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 8
Time Frame:
On day 8

Secondary Outcome

The number of participants with adverse events
Participants who had adverse events during the study
Time Frame:
Up to 3 weeks
The number of participants who discontinued from treatment
Participants who discontinued from study treatment
Time Frame:
Up to 3 weeks
The number of participants with the need of further treatment
Participants who needed further treatment
Time Frame:
Up to 3 weeks

Trial design

Non-interventional study on the onset of effect of Iberogast in patients with functional or motility-related gastrointestinal diseases

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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