Functional Gastrointestinal DisordersPhase 2NCT04059900
Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus
A Phase 2 study testing STW5 (Iberogast®, BAY98-7411) in people with Functional Gastrointestinal Disorders, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- STW5 (Iberogast®, BAY98-7411)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jun 2009to 3 May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- STW5 (Iberogast®, BAY98-7411), Placebo
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STW5 (Iberogast®, BAY98-7411)Drug
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.
PlaceboDrug
The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals
| Study group | Role | What they receive |
|---|---|---|
| STW5 (Iberogast®, BAY98-7411) | Experimental | 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. Receives: Drug: STW5 (Iberogast®, BAY98-7411) |
| Placebo | Placebo comparator | The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 28 days
Secondary outcomes (14)
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).
Measured: 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.
Measured: 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)
Measured: 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".
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start18 Jun 2009
- Primary completion3 May 2013
- Study completion3 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059900
- Sponsor's protocol ID
- 20985
- Other IDs
- 2008-002305-40, 2008
- Status last verified
- Sep 2019
- First submitted
- 12 Jul 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04059900
- Acronym / sponsor ID
- 20985
- Conditions
- Functional Gastrointestinal Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2009 (actual)
- Primary completion
- 3 May 2013 (actual)
- Study completion
- 3 May 2013 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STW5 (Iberogast®, BAY98-7411) | Experimental | 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 | Placebo comparator | Drug: PlaceboThe medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients of either sex aged 18-80 years.
- Diagnosis of functional dyspepsia according to Rome III criteria:
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| PlaceboThe 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 |
Primary outcome
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)
14 secondary outcomes
Global Subject Outcome Assessment at visit 5
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)
Time frame: At baseline and day 28
AUC of reflux symptoms assessment measured by daily VAS scale
Time frame: Up to 28 days
Quality of Life evaluation as assessed by Functional Dyspepsia Quality of Life (FDDQL)
Time frame: At baseline and day 28
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
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
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
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
Calculation of the DeMeester Score based on intraluminal impedance
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
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
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
Time frame: At day 28
Global assessment of efficacy judged by physician using a five point Likert scale
Time frame: At day 28
Change of Individual symptom score from baseline at the end of study (day 28)
Time frame: At baseline and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STW5 (Iberogast®, BAY98-7411) in people with Functional Gastrointestinal Disorders, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale. (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.