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Imonogas

Phase 3

Functional Dyspepsia | Small molecule | Gastrointestinal |Johnson & Johnson|Last Updated: Dec 15, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment210

FDA Designations

No designations recorded

Clinical trial landscape

Imonogas · 1 trial · 1 indication

Phase 3 1
NCT02660372Efficacy and Safety of Two Simeticone Brands in Adults With Functional DyspepsiaFunctional Dyspepsia
COMPLETED210 Analytics
PHASE3COMPLETED
Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia
Functional DyspepsiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Aggregate symptom score calculated from subjects assessment of 10 individual upper gastrointestinal symptoms 8 weeks after start of treatments
8 weeks

Specific questionnaire with a 4 point scale

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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ImonogasEXPERIMENTALImonogas 120 mg, 1 capsule three times daily for 8 weeks
EspumisanACTIVE_COMPARATOREspumisan 40 mg, 2 capsules four times daily for 8 weeks

Interventions

NameTypeDescription
ImonogasDRUGSimethicone 120 mg in gel capsules
EspumisanDRUGSimethicone 40 mg in gel capsules
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subjects of the age of 18 years or older with a suspected diagnosis of functional dyspepsia according to Rome III criteria (see Appendix A) e.g. subjects suffering from bothersome postprandial fullness or early satiation or epigastric pain or epigastric burning AND no evidenc...

Countries:Russia
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Frequently asked questions about Imonogas

What is Imonogas used for?

Imonogas is an investigational small molecule being developed for the treatment of functional dyspepsia, a gastrointestinal condition characterized by chronic indigestion symptoms. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes Imonogas?

Imonogas is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with functional dyspepsia.

What phase is Imonogas in?

Imonogas is in Phase 3 clinical development for functional dyspepsia. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and effectiveness in the target patient population.

What clinical trials is Imonogas in?

Imonogas has been studied in one completed Phase 3 clinical trial, identified as NCT02660372. This trial, titled 'Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia,' enrolled 210 participants in Russia and evaluated the drug's effects in adults aged 18 years and older.

Is Imonogas the same as simeticone?

Imonogas is being studied in a clinical trial that compares two brands of simeticone, a common anti-foaming agent used for digestive symptoms. However, the available information does not specify whether Imonogas itself is a simeticone product or a distinct compound being evaluated in the same trial context.