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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370863
Recruitment Status : Terminated (This study was terminated early due to recruitment difficulties. There were no safety concerns.)
First Posted : June 10, 2011
Results First Posted : June 7, 2013
Last Update Posted : July 11, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: SPD557 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks [ Time Frame: 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 :
  1. Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks [ Time Frame: Baseline and 4 weeks ]
  2. 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 ]
    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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01370863

CUB Hôpital Erasme
Brussels, Bruxelles, Belgium, 1070
Cliniques universitaires Saint Luc
Bruxelles, Belgium, 1200
UZ Leuven, Belgium
Leuven, Belgium, 3000
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
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, Germany, 82467
Otto-von-Guericke University
Magdeburg, Germany, 39120
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands, 1105 AZ
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
Study Director: An Rykx, PhD Shire-Movetis
Principal Investigator: Prof. Jan Tack, M.D. KUL, Herestraat 49, 3000 Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shire Identifier: NCT01370863     History of Changes
Other Study ID Numbers: SPD557-202
2010-021397-12 ( EudraCT Number )
First Posted: June 10, 2011    Key Record Dates
Results First Posted: June 7, 2013
Last Update Posted: July 11, 2014
Last Verified: April 2014

Keywords provided by Shire:
Gastroesophageal reflux disease
Proton pump inhibitors

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases