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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SPD557
placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Gastroesophageal reflux disease, SPD557, Proton pump inhibitors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CUB Hôpital Erasme
  • Cliniques universitaires Saint Luc
  • UZ Leuven, Belgium
  • CHU de Bordeaux - Hôpital Saint André
  • CHU de Lyon - Groupement Hospitalier Edouard Herriot
  • Hôtel Dieu - CHU de Nantes
  • Klinikum Garmisch-Partenkirchen GmbH
  • Otto-von-Guericke University
  • Academisch Medisch Centrum (AMC)
  • Inselspital Bern (Bern University Hopsital)
  • Kantonsspital St. Gallen
  • University Hospital Zurich
  • Addenbrooke's Hospital
  • Wingate Institute of Neurogastroenterology
  • Queen's Medical Center (Nottingham University Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SPD557

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2011
Last Updated
May 29, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01370863
Brief Title
An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients
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 Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to recruitment difficulties. There were no safety concerns.
Study Start Date
December 2, 2010 (Actual)
Primary Completion Date
May 29, 2012 (Actual)
Study Completion Date
May 29, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD, Gastroesophageal reflux disease, SPD557, Proton pump inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPD557
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD557
Intervention Description
0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks
Description
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 Outcome Measure Information:
Title
Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks
Time Frame
Baseline and 4 weeks
Title
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
CUB Hôpital Erasme
City
Brussels
State/Province
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven, Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Bordeaux - Hôpital Saint André
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Facility Name
CHU de Lyon - Groupement Hospitalier Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôtel Dieu - CHU de Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Klinikum Garmisch-Partenkirchen GmbH
City
Garmisch-Partenkirchen
ZIP/Postal Code
82467
Country
Germany
Facility Name
Otto-von-Guericke University
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Inselspital Bern (Bern University Hopsital)
City
Bern
ZIP/Postal Code
BHH D140
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Wingate Institute of Neurogastroenterology
City
London
ZIP/Postal Code
E12AJ
Country
United Kingdom
Facility Name
Queen's Medical Center (Nottingham University Hospital)
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25530111
Citation
Tack J, Zerbib F, Blondeau K, des Varannes SB, Piessevaux H, Borovicka J, Mion F, Fox M, Bredenoord AJ, Louis H, Dedrie S, Hoppenbrouwers M, Meulemans A, Rykx A, Thielemans L, Ruth M. Randomized clinical trial: effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment. Neurogastroenterol Motil. 2015 Feb;27(2):258-68. doi: 10.1111/nmo.12484. Epub 2014 Dec 21.
Results Reference
derived

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

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