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

Phase 2TerminatedNCT01370863

Shire67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

SPD557DRUG

0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment

placeboDRUG

matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (15)

CUB Hôpital Erasme

Brussels, Brussels Capital, Belgium

Cliniques universitaires Saint Luc

Brussels, Belgium

UZ Leuven, Belgium

Leuven, Belgium

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 4 weeks

Secondary Outcomes

Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks

Time frame: 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.

Time frame: Baseline and 4 weeks

Data from ClinicalTrials.gov

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