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STW5

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment243

FDA Designations

No designations recorded

Clinical trial landscape

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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Frequently asked questions about STW5

What is STW5 used for?

STW5 is an investigational small molecule being developed for functional gastrointestinal disorders and irritable bowel syndrome. It is a plant-based combination product being studied for its effects on digestive symptoms. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes STW5?

STW5 is being developed by Bayer AG, a multinational pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gastrointestinal conditions.

What phase is STW5 in?

STW5 is in Phase 2 clinical development. The drug has completed one Phase 2 trial and one Phase 3 trial, both in Germany. It remains investigational and has not received regulatory approval for any indication.

What clinical trials is STW5 in?

STW5 has been studied in two completed clinical trials. NCT01940848 was a Phase 3 study in 243 patients with irritable bowel syndrome, and NCT04059900 was a Phase 2 study in 64 patients with functional gastrointestinal disorders. Both trials were conducted in Germany.

Is STW5 the same as Iberogast?

STW5 is the active ingredient in Iberogast, a commercial product. The clinical trial NCT01940848 was designed to confirm Iberogast's efficacy in patients with irritable bowel syndrome. STW5 is the pharmaceutical name used in clinical research for this combination product.