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

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ClinicalTrials.gov Identifier: NCT04059783
Recruitment Status : Completed
First Posted : August 16, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Functional Gastrointestinal Disorders Drug: STW5 (Iberogast®, BAY98-7411)

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Study Type : Observational
Actual Enrollment : 272 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on the Onset of Effect of Iberogast in Patients With Functional or Motility-related Gastrointestinal Diseases
Actual Study Start Date : June 17, 2008
Actual Primary Completion Date : April 27, 2010
Actual Study Completion Date : February 20, 2011

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male or female patients of at least 18 years were to be observed
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059783


Locations
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Germany
Many locations
Multiple Locations, Germany
Sponsors and Collaborators
Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04059783     History of Changes
Other Study ID Numbers: 20984
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases