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

This study has been terminated.
(This study was terminated early due to recruitment difficulties. There were no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01370863
First received: May 31, 2011
Last updated: June 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: SPD557
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 67
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD557 Drug: SPD557
0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
Placebo Comparator: Placebo Drug: placebo
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370863

Locations
Belgium
CUB Hôpital Erasme
Brussels, Bruxelles, Belgium, 1070
Cliniques universitaires Saint Luc
Bruxelles, Belgium, 1200
UZ Leuven, Belgium
Leuven, Belgium, 3000
France
CHU de Bordeaux - Hôpital Saint André
Bordeaux Cedex, France, 33075
CHU de Lyon - Groupement Hospitalier Edouard Herriot
Lyon, France, 69437
Hôtel Dieu - CHU de Nantes
Nantes Cedex 1, France, 44093
Germany
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, Germany, 82467
Otto-von-Guericke University
Magdeburg, Germany, 39120
Netherlands
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands, 1105 AZ
Switzerland
Inselspital Bern (Bern University Hopsital)
Bern, Switzerland, BHH D140
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
University Hospital Zurich
Zurich, Switzerland, CH-8091
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Wingate Institute of Neurogastroenterology
London, United Kingdom, E12AJ
Queen's Medical Center (Nottingham University Hospital)
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Shire
Investigators
Study Director: An Rykx, PhD Shire-Movetis
Principal Investigator: Prof. Jan Tack, M.D. KUL, Herestraat 49, 3000 Leuven
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01370863     History of Changes
Other Study ID Numbers: SPD557-202, 2010-021397-12
Study First Received: May 31, 2011
Results First Received: April 15, 2013
Last Updated: June 25, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Switzerland: Federal Office of Public Health
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Shire:
GERD
Gastroesophageal reflux disease
SPD557
Proton pump inhibitors

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014