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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment480

FDA Designations

No designations recorded

Clinical trial landscape

SSP-002358+ PPI · 1 trial · 1 indication

Phase 2 1
NCT01472939Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)Gastroesophageal Reflux Disease
COMPLETED480 Analytics
PHASE2COMPLETED
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux Disease
NCT01472939480
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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 to 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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Frequently asked questions about SSP-002358+ PPI

What is SSP-002358 used for?

SSP-002358 is an investigational small molecule being studied for use in healthy volunteers and in patients with Gastroesophageal Reflux Disease (GERD). It is being developed by Takeda Pharmaceutical Company Limited (TAK). The drug is currently in clinical development, with studies completed in both healthy subjects and GERD patients.

What does SSP-002358 target?

SSP-002358 is a selective 5-HT4 receptor agonist, as indicated by the clinical trial title. It is being studied in combination with a proton pump inhibitor (PPI) for the treatment of Gastroesophageal Reflux Disease (GERD). The drug is developed by Takeda Pharmaceutical Company Limited (TAK).

Who makes SSP-002358?

SSP-002358 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule in clinical development for Gastroesophageal Reflux Disease (GERD) and has been studied in healthy volunteers as well.

What phase is SSP-002358 in?

SSP-002358 is in clinical development, with completed trials in Phase 1 and Phase 2. The Phase 1 trial studied drug interactions with omeprazole in healthy volunteers, and the Phase 2 trial evaluated the drug in patients with Gastroesophageal Reflux Disease (GERD). It is not approved and remains investigational.

What clinical trials is SSP-002358 in?

SSP-002358 has two completed clinical trials. NCT01415349 was a Phase 1 drug interaction study with omeprazole in healthy volunteers in the Netherlands. NCT01472939 was a Phase 2 study of the drug combined with a proton pump inhibitor in subjects with Gastroesophageal Reflux Disease (GERD), conducted in the US, Czechia, Germany, Latvia, Poland, and Romania.

Is SSP-002358 the same as a 5-HT4 receptor agonist?

SSP-002358 is described as a selective 5-HT4 receptor agonist in the clinical trial title. It is being studied in combination with a proton pump inhibitor for Gastroesophageal Reflux Disease (GERD). The drug is developed by Takeda Pharmaceutical Company Limited (TAK) and is currently investigational.