check_circleStudy Completed
Functional Gastrointestinal Disorders
Bayer Identifier:
20985
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study in patients suffering from heartburn and backward flow of stomach liquid into the esophagus
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - 80 YearsTrial summary
Enrollment Goal
64Trial Dates
June 2009 - May 2013Phase
Phase 2Could I Receive a placebo
YesProducts
Iberogast (STW5, BAY98-7411)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Germany |
Primary Outcome
- 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)date_rangeTime Frame:Up to 28 days
Secondary Outcome
- Global Subject Outcome Assessment at visit 5Assessed by Global Improvement Scale (substantially worsened/moderately worsened/ marginally worsened/not changed/ marginally improved/ moderately improved/ substantially improved).date_rangeTime 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.date_rangeTime Frame:At baseline and day 28
- AUC of reflux symptoms assessment measured by daily VAS scaleArea 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)date_rangeTime 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".date_rangeTime Frame:At baseline and day 28
- Relative time with an esophageal pH < 4 during 24 hours of measurement by Bravo™ pH systemThe 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 beltdate_rangeTime 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 impedancepH measured by pH-metrydate_rangeTime Frame:At day -1 (screening phase) and day 29/30 if applicable
- Calculation of the DeMeester Score measured based on Bravo™ pH systemThe 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 periodsdate_rangeTime 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 systemThe 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)date_rangeTime Frame:At day -7/ -5 (screening phase) and day 29/30 if applicable
- Calculation of the DeMeester Score based on intraluminal impedanceThe 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)date_rangeTime 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 impedanceImpedance 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 possibledate_rangeTime Frame:At day -1 (screening phase) and day 29/30 if applicable
- Symptom index measurement in parallel to the pH measurement by intraluminal impedanceThe 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).date_rangeTime Frame:At day -1 (screening phase) and day 29/30 if applicable
- Global assessment of efficacy judged by patient using a five point Likert scale1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poordate_rangeTime Frame:At day 28
- Global assessment of efficacy judged by physician using a five point Likert scale1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poordate_rangeTime 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 severedate_rangeTime Frame:At baseline and day 28
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Supportive CareAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2