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NCT Number: NCT01472939

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hepato-Gastroenterology HK s.r.o., Hradec Králové, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
  • Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
  • Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
  • Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)

Exclusion criteria

  • Subjects who show no response to heartburn while on PPI therapy.
  • Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
  • Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
  • Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.
  • Alarm symptoms suggestive of malignancies or organic disease.

Treatment and study plan

SSP-002358 (0.1 mg) + PPI

Drug

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

Other names: SPD557

SSP-002358 (0.5 mg) + PPI

Drug

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

SSP-002358 (2.0 mg) + PPI

Drug

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

Placebo + PPI

Drug

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

Primary outcomes

  1. Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8

    Time frame: Baseline and over weeks 5-8

Secondary outcomes

  1. Change From Baseline in Heartburn-Free Days Over Weeks 5-8

    Time frame: Baseline and over weeks 5-8

  2. Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8

    Time frame: Baseline and over weeks 5-8

    PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.

  3. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358

    Time frame: Over 8 hours post-dose (week 2 or later)

    Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

  4. Steady State Maximum Plasma Concentration (Cmax) of SSP-002358

    Time frame: Over 8 hours post-dose (week 2 or later)

    Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.

  5. Time to Maximum Plasma Concentration (Tmax) of SSP-002358

    Time frame: Over 8 hours post-dose (week 2 or later)

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) With Persistent Regurgitation With or Without Heartburn

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2011
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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