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

Study Overview
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Brief Summary
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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.

Official Title
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An Explorative, Randomized, Placebo-controlled, DB, Parallel-group Trial, to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Subjects With GERD & With Persistent Symptoms Despite Taking a Stable Dose of PPIs

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: SPD557
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Written ICF signed voluntarily before the first trial related activity. Subjects with a history of GERD symptoms (i.e., heartburn and/or regurgitation) during the last 6 months Subjects on a stable dose of PPIs, compliant for at least 6 weeks prior to screening. ≥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: 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 or lung disease, neurologic, cancer or AIDS. Alarm symptoms suggestive of malignancies or organic disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPD557<br> | Drug: SPD557<br>* 0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks | This is used to characterize gastric reflux events. The measurements were made over a 24-hour period at baseline and again at week 4. | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks |  | Baseline and 4 weeks | 
| Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks | The PAGI-SYM contains 20 items and the scores range from 0 (no symptoms)-5 (very severe symptoms) for each item with a total score of 0-100. Higher scores indicate more severe gastrointestinal symptoms. | Baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Proton pump inhibitors, Gastroesophageal reflux disease, SPD557