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Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus

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ClinicalTrials.gov Identifier: NCT04059900
Recruitment Status : Completed
First Posted : August 16, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Drug: STW5 (Iberogast®, BAY98-7411) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 18, 2009
Actual Primary Completion Date : May 3, 2013
Actual Study Completion Date : May 3, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

Arm Intervention/treatment
Experimental: STW5 (Iberogast®, BAY98-7411)
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 per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

Placebo Comparator: Placebo
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 p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals




Primary Outcome Measures :
  1. AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale. [ Time Frame: Up to 28 days ]
    Area under the curve (AUC) of patients` assessment of gastrointestinal symptoms evaluated by daily visual analogue scale (VAS)


Secondary Outcome Measures :
  1. Global Subject Outcome Assessment at visit 5 [ Time Frame: At day 28 (visit 5) ]
    Assessed by Global Improvement Scale (substantially worsened/moderately worsened/ marginally worsened/not changed/ marginally improved/ moderately improved/ substantially improved).

  2. Change of the Gastrointestinal Symptoms Profile (GIS) from baseline (visit 3) at the end of study (day 28) [ Time Frame: At baseline and 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.

  3. AUC of reflux symptoms assessment measured by daily VAS scale [ Time Frame: Up to 28 days ]
    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)

  4. Quality of Life evaluation as assessed by Functional Dyspepsia Quality of Life (FDDQL) [ Time Frame: At baseline and day 28 ]
    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".

  5. Relative time with an esophageal pH < 4 during 24 hours of measurement by Bravo™ pH system [ Time Frame: At day -7/ -5 (screening phase) and day 29/30 if applicable ]
    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

  6. Relative time with an esophageal pH < 4 during 24 hours of measurement using intraluminal impedance [ Time Frame: At day -1 (screening phase) and day 29/30 if applicable ]
    pH measured by pH-metry

  7. Calculation of the DeMeester Score measured based on Bravo™ pH system [ Time Frame: At day -7/ -5 (screening phase) and day 29/30 if applicable ]
    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

  8. System index measurement in parallel to the pH measurement by Bravo™ pH system [ Time Frame: At day -7/ -5 (screening phase) and day 29/30 if applicable ]
    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)

  9. Calculation of the DeMeester Score based on intraluminal impedance [ Time Frame: At day -1 (screening phase) and day 29/30 if applicable ]
    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)

  10. 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 [ Time Frame: At day -1 (screening phase) and day 29/30 if applicable ]
    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

  11. Symptom index measurement in parallel to the pH measurement by intraluminal impedance [ Time Frame: At day -1 (screening phase) and day 29/30 if applicable ]
    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).

  12. Global assessment of efficacy judged by patient using a five point Likert scale [ Time Frame: At day 28 ]
    1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor

  13. Global assessment of efficacy judged by physician using a five point Likert scale [ Time Frame: At day 28 ]
    1 = very good, 2 = good, 3 = moderate, 4 = poor, 5 = very poor

  14. Change of Individual symptom score from baseline at the end of study (day 28) [ Time Frame: At baseline and 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of either sex aged 18-80 years.
  2. 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.
  3. 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.
  4. 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).
  5. Patients willing to comply with the study protocol.
  6. Patients who were able to understand and provide written informed consent to participate in the trial (signed informed consent).

Exclusion Criteria:

  1. 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).
  2. Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2 (COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
  3. History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer.
  4. History of gastric and/or duodenal ulcer.
  5. History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).
  6. History and/or presence of coronary heart disease.
  7. Known intolerance to azo dyes E 110 and E 151.
  8. Food allergies and known lactose intolerance.
  9. Evidence of any gastrointestinal infectious diseases.
  10. Participation in a clinical trial 30 days prior to this trial.
  11. Concurrent participation in another clinical trial.
  12. Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
  13. History and/or presence of drug or alcohol abuse.
  14. Patients with psychiatric illness.
  15. Irritable bowel syndrome.

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): NCT04059900


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: NCT04059900     History of Changes
Other Study ID Numbers: 20985
2008-002305-40 ( EudraCT Number )
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