Back to resultsStudy in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus
Primary Purpose
Functional Gastrointestinal Disorders
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
STW5 (Iberogast®, BAY98-7411)
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Functional Gastrointestinal Disorders
Eligibility Criteria
Inclusion Criteria:
- Patients of either sex aged 18-80 years.
Diagnosis of functional dyspepsia according to Rome III criteria:
- Pain or burning localized to the epigastrium of at least moderate severity at least once per week with a total duration of at least 6 months.
- Pain was intermittent.
- Pain was not generalized or localized to other abdominal or chest regions.
- Pain was not relieved by defecation or passage of flatus.
- Pain did not fulfil criteria for gallbladder and sphincter of Oddi disorders.
- At assessment (visit 1 or 3) three items of GIS had to be judged at least as moderate including reflux symptoms, but reflux symptoms not dominating the clinical picture.
- Endoscopy of the upper gastrointestinal tract and abdominal sonography without pathological findings that could have explained the symptoms (findings of up to 5 gastric erosions could be tolerated if patient had no concomitant intake of acetylsalicylic acid).
- Patients willing to comply with the study protocol.
- Patients who were able to understand and provide written informed consent to participate in the trial (signed informed consent).
Exclusion Criteria:
- Concomitant treatment during the study with any medication that could influence the gastrointestinal function (e.g. prokinetics, antacids, antibiotics, antidepressant, laxatives, calcium antagonists, beta-blocker, antidiarrheics).
- Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2 (COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
- History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer.
- History of gastric and/or duodenal ulcer.
- History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).
- History and/or presence of coronary heart disease.
- Known intolerance to azo dyes E 110 and E 151.
- Food allergies and known lactose intolerance.
- Evidence of any gastrointestinal infectious diseases.
- Participation in a clinical trial 30 days prior to this trial.
- Concurrent participation in another clinical trial.
- Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
- History and/or presence of drug or alcohol abuse.
- Patients with psychiatric illness.
- Irritable bowel syndrome.
Sites / Locations
- Many locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
STW5 (Iberogast®, BAY98-7411)
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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).
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.
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)
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".
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
Relative time with an esophageal pH < 4 during 24 hours of measurement using intraluminal impedance
pH measured by pH-metry
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
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)
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)
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
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).
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04059900
Brief Title
Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus
Official Title
A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW 5) in Patients With Functional Dyspepsia and Concomitant Reflux Symptoms Measured With Impedance and Wireless pH Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 18, 2009 (Actual)
Primary Completion Date
May 3, 2013 (Actual)
Study Completion Date
May 3, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STW5 (Iberogast®, BAY98-7411)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals
Intervention Type
Drug
Intervention Name(s)
STW5 (Iberogast®, BAY98-7411)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals
Primary Outcome Measure Information:
Title
AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale.
Description
Area under the curve (AUC) of patients' assessment of gastrointestinal symptoms evaluated by daily visual analogue scale (VAS)
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Global Subject Outcome Assessment at visit 5
Description
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)
Title
Change of the Gastrointestinal Symptoms Profile (GIS) from baseline (visit 3) at the end of study (day 28)
Description
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
Title
AUC of reflux symptoms assessment measured by daily VAS scale
Description
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
Title
Quality of Life evaluation as assessed by Functional Dyspepsia Quality of Life (FDDQL)
Description
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
Title
Relative time with an esophageal pH < 4 during 24 hours of measurement by Bravo™ pH system
Description
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
Title
Relative time with an esophageal pH < 4 during 24 hours of measurement using intraluminal impedance
Description
pH measured by pH-metry
Time Frame
At day -1 (screening phase) and day 29/30 if applicable
Title
Calculation of the DeMeester Score measured based on Bravo™ pH system
Description
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
Title
System index measurement in parallel to the pH measurement by Bravo™ pH system
Description
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
Title
Calculation of the DeMeester Score based on intraluminal impedance
Description
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
Title
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
Description
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
Title
Symptom index measurement in parallel to the pH measurement by intraluminal impedance
Description
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
Title
Global assessment of efficacy judged by patient using a five point Likert scale
Description
1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor
Time Frame
At day 28
Title
Global assessment of efficacy judged by physician using a five point Likert scale
Description
1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor
Time Frame
At day 28
Title
Change of Individual symptom score from baseline at the end of study (day 28)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of either sex aged 18-80 years.
Diagnosis of functional dyspepsia according to Rome III criteria:
Pain or burning localized to the epigastrium of at least moderate severity at least once per week with a total duration of at least 6 months.
Pain was intermittent.
Pain was not generalized or localized to other abdominal or chest regions.
Pain was not relieved by defecation or passage of flatus.
Pain did not fulfil criteria for gallbladder and sphincter of Oddi disorders.
At assessment (visit 1 or 3) three items of GIS had to be judged at least as moderate including reflux symptoms, but reflux symptoms not dominating the clinical picture.
Endoscopy of the upper gastrointestinal tract and abdominal sonography without pathological findings that could have explained the symptoms (findings of up to 5 gastric erosions could be tolerated if patient had no concomitant intake of acetylsalicylic acid).
Patients willing to comply with the study protocol.
Patients who were able to understand and provide written informed consent to participate in the trial (signed informed consent).
Exclusion Criteria:
Concomitant treatment during the study with any medication that could influence the gastrointestinal function (e.g. prokinetics, antacids, antibiotics, antidepressant, laxatives, calcium antagonists, beta-blocker, antidiarrheics).
Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2 (COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer.
History of gastric and/or duodenal ulcer.
History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).
History and/or presence of coronary heart disease.
Known intolerance to azo dyes E 110 and E 151.
Food allergies and known lactose intolerance.
Evidence of any gastrointestinal infectious diseases.
Participation in a clinical trial 30 days prior to this trial.
Concurrent participation in another clinical trial.
Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
History and/or presence of drug or alcohol abuse.
Patients with psychiatric illness.
Irritable bowel syndrome.
Facility Information:
Facility Name
Many locations
City
Multiple Locations
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus
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