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SSP-002358 + PPI

Phase 2

Gastroesophageal Reflux Disease | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Jun 9, 2021

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-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment480
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01472939Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)PHASE2 COMPLETED 480 — — Feb 27, 2012May 14, 2013Jun 9, 202188 United States, Czechia +4
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Study Endpoints
Primary Endpoints
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
Baseline and over weeks 5-8
Secondary Endpoints
Change From Baseline in Heartburn-Free Days Over Weeks 5-8
Baseline and over weeks 5-8
Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8
Baseline and over weeks 5-8
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358
Over 8 hours post-dose (week 2 or later)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)ACTIVE_COMPARATOR -
SSP-002358 (0.5 mg) + PPIACTIVE_COMPARATOR -
SSP-002358 (2.0 mg) + PPIACTIVE_COMPARATOR -
Placebo + PPIPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SSP-002358 (0.1 mg) + PPIDRUG0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
SSP-002358 (0.5 mg) + PPIDRUG0.5 mg tablet t.i.d. taken in addition to a PPI
SSP-002358 (2.0 mg) + PPIDRUG2.0 mg tablet t.i.d. taken in addition to a PPI
Placebo + PPIDRUGPlacebo t.i.d. taken in addition to a PPI
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites88

Inclusion Criteria: 1. Written Informed Consent Form signed voluntarily before the first study-related activity. 2. Aged between 18 and 70 years, inclusive. 3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy. 4. Subjects with symptoms...

Countries:United StatesCzechiaGermanyLatviaPolandRomania
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