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

NCT01472939 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-06-09

Study results available
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Summary

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.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

SSP-002358 (0.1 mg) + PPI

0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI

DRUG

SSP-002358 (0.5 mg) + PPI

0.5 mg tablet t.i.d. taken in addition to a PPI

DRUG

SSP-002358 (2.0 mg) + PPI

2.0 mg tablet t.i.d. taken in addition to a PPI

DRUG

Placebo + PPI

Placebo t.i.d. taken in addition to a PPI

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-27
Primary Completion
2013-05-14
Completion
2013-05-14

Countries

  • United States
  • Czechia
  • Germany
  • Latvia
  • Poland
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472939 on ClinicalTrials.gov