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STW5

Phase 3

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Bayer AG|Trials Updated: Sep 19, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment307

FDA Designations

No designations recorded

STW5 clinical trials

STW5 · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT01940848Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to PlaceboIrritable Bowel Syndrome
COMPLETED243 Analytics
PHASE3COMPLETED
Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo
Irritable Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
28 days (+/- 3 days)

The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale

AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale.
Up to 28 days

Area under the curve (AUC) of patients' assessment of gastrointestinal symptoms evaluated by daily visual analogue scale (VAS)

Secondary Endpoints

Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment
14 days (+/- 3 days)
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
28 days (+/- 3 days)
Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
28 days (+/- 3 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
STW5EXPERIMENTAL2/3 patients with irritable bowel syndrome will be randomized in this arm
PlaceboPLACEBO_COMPARATOR1/3 patients with irritable bowel syndrome will be randomized in this arm
STW5 (Iberogast®, BAY98-7411)EXPERIMENTALThe 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.

Interventions

NameTypeDescription
STW5 (Iberogast, BAY98-7411)DRUGApplied orally over 28 days, 20 drops STW 5 three times daily
PlaceboDRUGApplied orally over 28 days, 20 drops placebo three times daily
STW5 (Iberogast®, BAY98-7411)DRUGThe 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * 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 ...

Countries:Germany
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Competitive Landscape -Irritable Bowel Syndrome 15 trials

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Frequently asked questions about STW5

What is STW5?

STW5 is an investigational small molecule developed by Bayer AG for functional gastrointestinal disorders and irritable bowel syndrome. It is also known as Iberogast and BAY98-7411. STW5 is currently in Phase 2 clinical development.

What is STW5 used for?

STW5 is being studied for functional gastrointestinal disorders and irritable bowel syndrome. Clinical trials have evaluated it in patients with heartburn and backward flow of stomach liquid into the esophagus, as well as in irritable bowel syndrome diagnosed by ROME III criteria.

Who makes STW5?

STW5 is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is responsible for the clinical development of STW5 for gastrointestinal indications.

What phase is STW5 in?

STW5 is in Phase 2 clinical development. One completed Phase 2 trial and one completed Phase 3 trial have been conducted. STW5 is investigational and has not been approved by the FDA for any indication.

What clinical trials is STW5 in?

STW5 has been evaluated in two completed trials: NCT04059900, a Phase 2 study in patients with heartburn and backward flow of stomach liquid into the esophagus, and NCT01940848, a Phase 3 study in irritable bowel syndrome. Both trials were conducted in Germany.

Is STW5 the same as Iberogast?

Yes, STW5 is also known as Iberogast and BAY98-7411. These names refer to the same investigational compound developed by Bayer AG for functional gastrointestinal disorders and irritable bowel syndrome.