Study to Learn More About the Onset of Effect of Iberogast in Patients Suffering From Abnormal Stomach and Intestine Function

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Non-interventional Study on the Onset of Effect of Iberogast in Patients With Functional or Motility-related Gastrointestinal Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059783
• Other study ID #: 20984
• Status: Completed
• Start date: June 17, 2008
• Est. completion date: February 20, 2011

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: February 20, 2011
• Est. primary completion date: April 27, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Drug:
• STW5 (Iberogast®, BAY98-7411)
The medication was applied 3 x 20 drops per day orally, before or at meals with some liquid, ideally three weeks

Locations

Country	Name	City	State
Germany	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline and up to 3 weeks post-treatment
Primary	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	Up to 3 weeks
Primary	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	Up to 3 weeks
Primary	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).	At baseline and up to 2 hours post-treatment on day 1
Primary	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	On day 1
Primary	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	On day 2
Primary	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	On day 3
Primary	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	On day 4
Primary	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	On day 5
Primary	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	On day 6
Primary	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	On day 7
Primary	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	On day 8
Secondary	The number of participants with adverse events	Participants who had adverse events during the study	Up to 3 weeks
Secondary	The number of participants who discontinued from treatment	Participants who discontinued from study treatment	Up to 3 weeks
Secondary	The number of participants with the need of further treatment	Participants who needed further treatment	Up to 3 weeks

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