Phase 2
N=480
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT01472939 ↗Enrolled (actual)
480
Serious AEs
0.2%
Results posted
Apr 2014
Primary outcome: Primary: Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8 — 36.96; 43.01; 44.37; 38.79 percentage of days — p=0.128
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SSP-002358 (0.1 mg) + PPI (Drug); SSP-002358 (0.5 mg) + PPI (Drug); SSP-002358 (2.0 mg) + PPI (Drug); Placebo + PPI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8 |
36.96; 43.01; 44.37; 38.79 | 0.128 |
| SECONDARY Change From Baseline in Heartburn-Free Days Over Weeks 5-8 |
21.76; 28.52; 30.68; 27.47 | 0.102 |
| SECONDARY Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8 |
-13.29; -15.77; -16.49; -15.44 | 0.064 |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358 |
1650; 8352; 42613 | — |
| SECONDARY Steady State Maximum Plasma Concentration (Cmax) of SSP-002358 |
648; 3374; 17900 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of SSP-002358 |
5.00; 5.07; 4.51 | — |
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.
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01472939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.