An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

Shire

Status and phase: Terminated; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: placebo; Drug: SPD557

Study type: Interventional

Funder types: Industry

Identifiers

NCT01370863

SPD557-202

2010-021397-12 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.

Enrollment: 67 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written ICF signed voluntarily before the first trial related activity.
2. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during the last 6 months
3. Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening.
4. ≥3 days per week with heartburn and/or regurgitation symptoms of at least moderate severity and a minimum of 25 liquid containing reflux events over 24h (pH/MII monitoring).

Exclusion criteria

1. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
2. Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic, cancer or AIDS.
3. 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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67 participants in 2 patient groups, including a placebo group

SPD557

Experimental group

Treatment:

Drug: SPD557

Placebo

Placebo Comparator group

Treatment:

Drug: placebo