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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: SSP-002358 (0.5 mg) + PPI; Drug: SSP-002358 (2.0 mg) + PPI; Drug: Placebo + PPI; Drug: SSP-002358 (0.1 mg) + PPI

• Registration Number: NCT01472939
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Study Start: 2012-02-27
• Primary Completion: 2013-05-14
• Study Completion: 2013-05-14
• Results First Submitted: 2014-03-04
• Results First Submitted QC: 2014-03-04
• Results First Posted: 2014-04-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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 of GERD for at least 6 months prior to the Screening Visit.
5. Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
6. Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
7. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSP-002358 (0.5 mg) + PPI	SSP-002358 (0.5 mg) + PPI	-
SSP-002358 (2.0 mg) + PPI	SSP-002358 (2.0 mg) + PPI	-
Placebo + PPI	Placebo + PPI	-
SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)	SSP-002358 (0.1 mg) + PPI	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8	Baseline and over weeks 5-8

Secondary Outcome Measures

Name	Time	Method
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	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.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358	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.
Steady State Maximum Plasma Concentration (Cmax) of SSP-002358	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.
Time to Maximum Plasma Concentration (Tmax) of SSP-002358	Over 8 hours post-dose (week 2 or later)

Trial Locations

Locations (82)

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Genova Clinical Research; 🇺🇸 Tucson, Arizona, United States

Lynn Institute of the Ozarks; 🇺🇸 Little Rock, Arkansas, United States

Preferred Research Partners, Inc; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Gastroenterology; 🇺🇸 North Little Rock, Arkansas, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Southern California Research Institute Medical Group Inc; 🇺🇸 Los Angeles, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Clinicos; 🇺🇸 Colorado Springs, Colorado, United States

Connecticut Gastroenterology Institute; 🇺🇸 Bristol, Connecticut, United States

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