Irritable Bowel SyndromePhase 3NCT01940848
Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo
A Phase 3 study testing STW5 (Iberogast, BAY98-7411) in people with Irritable Bowel Syndrome, run by Bayer at 19 sites in Germany.
Trial summary
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- 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
- 243 participants
- Where
- 19 sitesGermany
- Study dates
- 11 Oct 2013to 25 Oct 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex aged >18 years
- Patients meeting the Rome III irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 3 days/month in last 3 months (onset at least 6 months ago) associated with two or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- History of pain intensity with an average of worst abdominal pain in past 24 hours score of > 30 on a daily measured VAS (visual analogue scale) during screening phase
Who cannot join
- Intake of STW5 within the last 5 years
- Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal function
- Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily)
- Patients with known hypersensitivity to any component of the trial drugs
- History of eating disorders
- Patients with a history of diseases with abdominal symptoms that can resemble IBS
Show all 9Show fewer
- Presence of any other acute or chronic gastrointestinal disorder
- History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously)
- Known intolerance to azo dyes E 110 and E 151
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites
Study site
Apolda, Thuringia, 99510
Study site
Berlin, 12157
Study site
Berlin, 13055
Study site
Blankenhain, Thuringia, 99444
Study site
Essen, North Rhine-Westphalia, 45355
Study site
Hagen, North Rhine-Westphalia, 58095
Study site
Halle, Saxony-Anhalt, 06108
Study site
Löhne, North Rhine-Westphalia, 32584
Study site
Lollar, Hesse, 35457
Study site
Ludwigsburg, Baden-Wurttemberg, 71640
Study site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067
Study site
Mannheim, Baden-Wurttemberg, 68165
Study site
Marl, North Rhine-Westphalia, 45770
Study site
Potsdam, Brandenburg, 14482
Study site
Reinfeld, Schleswig-Holstein, 23858
Study site
Sinzheim, Baden-Wurttemberg, 76547
Study site
Wardenburg, Lower Saxony, 26203
Study site
Wiesbaden, Hesse, 65185
Study site
Winsen, Lower Saxony, 21423
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"
- Conditions
- Irritable Bowel Syndrome
- Being tested
- STW5 (Iberogast, BAY98-7411), Placebo
- Keywords
- Iberogast, efficacy, safety
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STW5 (Iberogast, BAY98-7411)Drug
Applied orally over 28 days, 20 drops STW 5 three times daily
PlaceboDrug
Applied orally over 28 days, 20 drops placebo three times daily
| Study group | Role | What they receive |
|---|---|---|
| STW5 | Experimental | 2/3 patients with irritable bowel syndrome will be randomized in this arm Receives: Drug: STW5 (Iberogast, BAY98-7411) |
| Placebo | Placebo comparator | 1/3 patients with irritable bowel syndrome will be randomized in this arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale
Measured: 28 days (+/- 3 days)
Secondary outcomes (8)
Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment
Measured: 14 days (+/- 3 days)
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
Measured: 28 days (+/- 3 days)
Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
Measured: 28 days (+/- 3 days)
Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline
Measured: 28 days (+/- 3 days)
Numbers of participants with adverse events (AEs)
Measured: 28 days (+/- 3 days)
Vital signs
blood pressure, heart rate, body weight
Measured: 28 days (+/- 3 days)
Laboratory parameters
haematology, blood chemistry, urinalysis
Measured: 28 days (+/- 3 days)
Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
Measured: 28 days (+/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study start11 Oct 2013
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940848
- Sponsor's protocol ID
- 17063
- Other IDs
- STW5/212-D-011-III-V, 2011-002613-10
- Status last verified
- Oct 2018
- First submitted
- 9 Sep 2013
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. 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® (STW5) in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01940848
- Acronym / sponsor ID
- 17063
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Iberogast, efficacy, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2013 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 12 Sep 2013 (estimated)
- 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.
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STW5 | Experimental | Drug: STW5 (Iberogast, BAY98-7411)2/3 patients with irritable bowel syndrome will be randomized in this arm |
| Placebo | Placebo comparator | Drug: Placebo1/3 patients with irritable bowel syndrome will be randomized in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of either sex aged >18 years
- Patients meeting the Rome III irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 3 days/month in last 3 months (onset at least 6 months ago) associated with two or more of the following:
- History of pain intensity with an average of worst abdominal pain in past 24 hours score of > 30 on a daily measured VAS (visual analogue scale) during screening phase
Key exclusion criteria (9 listed)
- Intake of STW5 within the last 5 years
- Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal function
- Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily)
- Patients with known hypersensitivity to any component of the trial drugs
- History of eating disorders
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)Applied orally over 28 days, 20 drops STW 5 three times daily | Drug | STW5 |
| PlaceboApplied orally over 28 days, 20 drops placebo three times daily | Drug | Placebo |
Primary outcome
Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
Time frame: 28 days (+/- 3 days)
The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale
8 secondary outcomes
Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment
Time frame: 14 days (+/- 3 days)
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
Time frame: 28 days (+/- 3 days)
Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
Time frame: 28 days (+/- 3 days)
Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline
Time frame: 28 days (+/- 3 days)
Numbers of participants with adverse events (AEs)
Time frame: 28 days (+/- 3 days)
Vital signs
Time frame: 28 days (+/- 3 days)
Laboratory parameters
Time frame: 28 days (+/- 3 days)
Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
Time frame: 28 days (+/- 3 days)
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 29 Oct 2018.
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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.
Bayer Study Director study director
Bayer
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STW5 (Iberogast, BAY98-7411) in people with Irritable Bowel Syndrome, run by Bayer at 19 sites 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 6 inclusion and 9 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment (time frame: 28 days (+/- 3 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 29 Oct 2018.