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

Phase 2

Terminated

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: placebo; Drug: SPD557

• Registration Number: NCT01370863
• Lead Sponsor: Shire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-02
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2012-05-29
• Study Completion: 2012-05-29
• Results First Submitted: 2013-04-15
• Results First Submitted QC: 2013-04-22
• Results First Posted: 2013-06-07
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-29
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
SPD557	SPD557	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
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	Baseline and 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.

Trial Locations

Locations (15)

CUB Hôpital Erasme; 🇧🇪 Brussels, Bruxelles, Belgium

Cliniques universitaires Saint Luc; 🇧🇪 Bruxelles, Belgium

UZ Leuven, Belgium; 🇧🇪 Leuven, Belgium

CHU de Bordeaux - Hôpital Saint André; 🇫🇷 Bordeaux Cedex, France

CHU de Lyon - Groupement Hospitalier Edouard Herriot; 🇫🇷 Lyon, France

Hôtel Dieu - CHU de Nantes; 🇫🇷 Nantes Cedex 1, France

Klinikum Garmisch-Partenkirchen GmbH; 🇩🇪 Garmisch-Partenkirchen, Germany

Otto-von-Guericke University; 🇩🇪 Magdeburg, Germany

Academisch Medisch Centrum (AMC); 🇳🇱 Amsterdam, Netherlands

Inselspital Bern (Bern University Hopsital); 🇨🇭 Bern, Switzerland

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