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Completed

NCT Number: NCT04059783

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

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

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STW5 (Iberogast®, BAY98-7411)

Drug

The medication was applied 3 x 20 drops per day orally, before or at meals with some liquid, ideally three weeks

Primary outcomes

  1. Change of GIS score from baseline up to 3 weeks after treatment

    Time frame: At baseline and up to 3 weeks post-treatment

    Gastrointestinal System Profile (GIS) includes 5 scores: 0=Not available, 1=Slight, 2=Moderate, 3=Severe, 4=Very severe

  2. Global assessment by the physicians using a 4-point likert scale

    Time frame: Up to 3 weeks

    Therapeutic success assessed by physicians. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms

  3. Global assessment by the patient using a 4-point likert scale

    Time frame: Up to 3 weeks

    Therapeutic success assessed by patient. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms

  4. Change of ratings of symptom severity on a 100-mm visual analogue scale (VAS) over time after intake of Iberogast

    Time frame: At baseline and up to 2 hours post-treatment on day 1

    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).

  5. Onset of improvement assessed by patient on day 1

    Time frame: 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

  6. Onset of improvement assessed by patient on day 2

    Time frame: 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

  7. Onset of improvement assessed by patient on day 3

    Time frame: 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

  8. Onset of improvement assessed by patient on day 4

    Time frame: 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

  9. Onset of improvement assessed by patient on day 5

    Time frame: 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

  10. Onset of improvement assessed by patient on day 6

    Time frame: 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

  11. Onset of improvement assessed by patient on day 7

    Time frame: 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

  12. Onset of improvement assessed by patient on day 8

    Time frame: 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

Secondary outcomes

  1. The number of participants with adverse events

    Time frame: Up to 3 weeks

    Participants who had adverse events during the study

  2. The number of participants who discontinued from treatment

    Time frame: Up to 3 weeks

    Participants who discontinued from study treatment

  3. The number of participants with the need of further treatment

    Time frame: Up to 3 weeks

    Participants who needed further treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 16, 2019
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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