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

Shire

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: SSP-002358 (2.0 mg) + PPI; Drug: SSP-002358 (0.1 mg) + PPI; Drug: SSP-002358 (0.5 mg) + PPI; Drug: Placebo + PPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01472939

SPD557-206

2011-004388-62 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 480 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 4 patient groups, including a placebo group

SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)

Active Comparator group

Treatment:

Drug: SSP-002358 (0.1 mg) + PPI

SSP-002358 (0.5 mg) + PPI

Active Comparator group

Treatment:

Drug: SSP-002358 (0.5 mg) + PPI

SSP-002358 (2.0 mg) + PPI

Active Comparator group

Treatment:

Drug: SSP-002358 (2.0 mg) + PPI

Placebo + PPI

Placebo Comparator group

Treatment:

Drug: Placebo + PPI