A Phase 2 interventional study of STW5 (Iberogast®, BAY98-7411) and Placebo in Functional Gastrointestinal Disorders, sponsored by Bayer. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Bayer · Phase 2, Interventional, and Supportive care
In this study researchers want to learn more about the effectiveness of Iberogast® in patients with irritable stomach and concomitant chronic or recurrent heartburn and backward flow of stomach liquid into the esophagus. 60 patients in the age range from 18 - 80 year will be treated over 4 weeks with Iberogast® or placebo - an inactive substance which looks identical to Iberogast®. Patients completed diaries will provide researchers with detailed information on the change of stomach and intestinal symptoms during the treatment period. In addition information on the acidity of the esophagus and stomach liquid will be collected.
628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.
This study's enrollment of 64 is below the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
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Diagnosis of functional dyspepsia according to Rome III criteria:
Exclusion Criteria:
The medication was applied daily per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.
Drug: STW5 (Iberogast®, BAY98-7411)
The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals
Drug: Placebo
The medication was applied daily per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.
The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals
AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale.
Area under the curve (AUC) of patients' assessment of gastrointestinal symptoms evaluated by daily visual analogue scale (VAS)
Time frame: Up to 28 days
Global Subject Outcome Assessment at visit 5
Assessed by Global Improvement Scale (substantially worsened/moderately worsened/ marginally worsened/not changed/ marginally improved/ moderately improved/ substantially improved).
Time frame: At day 28 (visit 5)
Change of the Gastrointestinal Symptoms Profile (GIS) from baseline (visit 3) at the end of study (day 28)
The GIS is a symptom related score, validated in German language, which allows the investigator to assess the dyspeptic symptoms by asking the patient for the following 10 items (GIS): epigastric pain / upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort and acid eructation/heartburn. The total GIS score is 40 points and an increasing summary score therefore represents a higher intensity of dyspeptic symptoms.
Time frame: At baseline and day 28
AUC of reflux symptoms assessment measured by daily VAS scale
Area under the curve (AUC) of assessment of reflux symptoms evaluated by daily visual analogue scale (VAS). VAS is an s an unmarked scale on a line 100 mm in length, indicating from 0 mm (no symptoms) to 100 mm (severe symptoms)
Time frame: Up to 28 days
Quality of Life evaluation as assessed by Functional Dyspepsia Quality of Life (FDDQL)
The FDDQL provided a profile with eight subscores (daily activities, anxiety, diet, sleep, discomfort, health perceptions, coping with disease and impact of stress) as well as a global score. Sub-scale scores and the global score were transformed to a range from "0 = Poor QoL" to "100= Good QoL".
Time frame: At baseline and day 28
Relative time with an esophageal pH < 4 during 24 hours of measurement by Bravo™ pH system
The Bravo™ pH system is a new, single use, disposable class I catheter free pH monitoring system, which involves the attachment of a miniaturised radiotelemetry pH capsule to the mucosal wall of the esophagus. It simultaneously measures the pH and transmits data to a pager-sized receiver clipped into the subject's belt
Time frame: At day -7/ -5 (screening phase) and day 29/30 if applicable
Relative time with an esophageal pH < 4 during 24 hours of measurement using intraluminal impedance
pH measured by pH-metry
Time frame: At day -1 (screening phase) and day 29/30 if applicable
Calculation of the DeMeester Score measured based on Bravo™ pH system
The score is calculated from the following parameters: percentual part of measurement with pH\<4, number of reflux periods with a duration of more than 5 minutes, duration of the longest reflux period and total number of reflux periods
Time frame: At day -7/ -5 (screening phase) and day 29/30 if applicable
System index measurement in parallel to the pH measurement by Bravo™ pH system
The study patients will be instructed to enter concomitant symptoms (heartburn and upper abdominal pain) which might occur during the measurement by pushing pre-programmed buttons on the data logger A positive symptom index is defined with \>50% (more than a half of the concomitant symptoms occur within 5 minutes after bolus exposition)
Time frame: At day -7/ -5 (screening phase) and day 29/30 if applicable
Calculation of the DeMeester Score based on intraluminal impedance
The score is calculated from the following parameters: percentual part of measurement with pH\<4, number of reflux periods with a duration of more than 5 minutes, duration of the longest reflux period and total number of reflux periods)
Time frame: At day -1 (screening phase) and day 29/30 if applicable
Bolus exposition time in minutes and as percentual part of measurement time for acid reflux, non-acid reflux and total (acid and non-acid) reflux using intraluminal impedance
Impedance is a measure of the total resistance to current flow between adjacent electrodes. As reflux contents are characterized by different conductivity, which is the inverse of impedance, a pH-independent accurate and practical qualitative analysis of refluxate is possible
Time frame: At day -1 (screening phase) and day 29/30 if applicable
Symptom index measurement in parallel to the pH measurement by intraluminal impedance
The study patients will be instructed to enter concomitant symptoms (heartburn, retrosternal discomfort, upper abdominal pain) which might occur during the measurement by pushing pre-programmed buttons on the data logger. A positive symptom index is defined with \>50% (more than a half of the concomitant symptoms occur within 5 minutes after bolus exposition).
Time frame: At day -1 (screening phase) and day 29/30 if applicable
Global assessment of efficacy judged by patient using a five point Likert scale
1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor
Time frame: At day 28
Global assessment of efficacy judged by physician using a five point Likert scale
1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor
Time frame: At day 28
Change of Individual symptom score from baseline at the end of study (day 28)
The GIS sub-scores for epigastric pain (item 1) and reflux symptoms (item 10). The sub-scores were assessed and analysed using the following scores: 0 = No problem, 1 = Mild problem, 2 = Moderate problem, 3 = Severe problem, 4 = Very severe
Time frame: At baseline and day 28
Plan to share: Undecided — 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.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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