Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)

Recruiting in Palo Alto (17 mi)

+87 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Shire

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.

Eligibility Criteria

Inclusion Criteria

Written Informed Consent Form signed voluntarily before the first study-related activity.

Aged between 18 and 70 years, inclusive.

Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.

Treatment Details

Interventions

• PPI (Proton Pump Inhibitor)
• SSP-002358 (5-HT4 Receptor Agonist)

Participant Groups

Group I: SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI) Active Control 1 Intervention

Group II: SSP-002358 (0.5 mg) + PPI Active Control 1 Intervention

Group III: SSP-002358 (2.0 mg) + PPI Active Control 1 Intervention

Group IV: Placebo + PPI Placebo Group 1 Intervention

PPI is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as PPIs for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcers
• Zollinger-Ellison syndrome
• Erosive esophagitis

🇺🇸 Approved in United States as PPIs for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcers
• Zollinger-Ellison syndrome
• Erosive esophagitis
• Helicobacter pylori eradication

🇨🇦 Approved in Canada as PPIs for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcers
• Zollinger-Ellison syndrome
• Erosive esophagitis

🇯🇵 Approved in Japan as PPIs for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcers
• Zollinger-Ellison syndrome
• Erosive esophagitis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Louisiana Research Center, LLC Shreveport, LA

Meritus Medical Center Hagerstown, MD

Clinical Research Group of Montana Bozeman, MT

Clinical Research Center of Nevada Las Vegas, NV

More Trial Locations

Who Is Running the Clinical Trial?

Shire Lead Sponsor

References