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UI05MSP015CT

Phase 3

Functional Dyspepsia | Small molecule | Other |United Therapeutics Corporation|Last Updated: Jul 21, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment143
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03225248Efficacy and Safety of UI05MSP015CT in Functional DyspepsiaPHASE3 COMPLETED 143Nov 5, 2014Oct 12, 2015Jul 21, 2017 -
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Study Endpoints
Primary Endpoints
Change of symptom score of functional dyspepsia
4weeks

Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

Secondary Endpoints
Change of symptom score of functional dyspepsia
2weeks
General symptom improvement
2weeks, 4weeks
NDI-K questionnaire
4weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
UI05MSP015CTEXPERIMENTALUI05MSP015CT and Placebo of Gasmotin
GasmotinACTIVE_COMPARATORPlacebo of UI05MSP015CT and Gasmotin
Interventions
NameTypeDescription
UI05MSP015CTDRUGUI05MSP015CT and Placebo of Gasmotin
GasmotinDRUGPlacebo of UI05MSP015CT and Gasmotin
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Eligibility Criteria
Age Range19 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Age \>19 years 2. Diagnosis of functional dyspepsia meeting Rome III criteria 3. At least three moderate or severe symptoms included in the Symptom Score 4. No structural lesions of upper gastrointestinal tract Exclusion Criteria: 1. History of dyspepsia unrelated to functi...

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