Back to resultsSelective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SSP-002358 (0.1 mg) + PPI
SSP-002358 (0.5 mg) + PPI
SSP-002358 (2.0 mg) + PPI
Placebo + PPI
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease
Eligibility Criteria
Inclusion Criteria:
- Written Informed Consent Form signed voluntarily before the first study-related activity.
- Aged between 18 and 70 years, inclusive.
- Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
- Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
- Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
- Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
- Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)
Exclusion Criteria:
- Subjects who show no response to heartburn while on PPI therapy.
- Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
- 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, lung or neurologic disease, cancer or AIDS.
- Alarm symptoms suggestive of malignancies or organic disease.
Sites / Locations
- HOPE Research Institute
- Genova Clinical Research
- Lynn Institute of the Ozarks
- Preferred Research Partners, Inc
- Arkansas Gastroenterology
- Anaheim Clinical Trials
- Southern California Research Institute Medical Group Inc
- Medical Center for Clinical Research
- Clinicos
- Connecticut Gastroenterology Institute
- Stamford Therapeutics Consortium
- Medical Research Unlimited, LLC
- Consultants for Clinical Research of South Florida
- PAB Clinical Research
- Avail Clinical Research, LLC
- S & W Clinical Research
- Medical Research Unlimited, LLC
- Jupiter Research
- Pines Clinical Research, Inc.
- Radiant Research
- Accord Clinical Research, LLC
- Meridien Research
- Gastrointestinal Specialists of GA, PC
- Digestive Research Associates
- Rockford Gastroenterology Associates, Ltd
- Professional Research Network of Kansas, LLC
- Research Integrity
- Clinical Trials Management
- Louisiana Research Center, LLC
- Meritus Medical Center
- Beacon Clinical Research
- Center for Digestive and Liver Diseases
- Clinical Research Group of Montana
- Meridian Clinical Research
- Clinical Research Center of Nevada
- New Jersey Physicians, LLC
- UNC Hospitals
- Carolinas Research Associates
- Cumberland Research Associates
- Vital Research, Inc.
- Carolinas Research Associates
- Peters Medical Research
- Wake Research Associates
- Prestige Clinical Research
- Oklahoma Foundation for Digestive Research Sciences Center
- Family Medical Associates
- Guthrie Clinic, Ltd.
- Omega Medical Research
- Meridian Clinical Research
- Clinsearch, LLC
- Radiant Research Dallas-North
- GI Consultants, P.A.
- Pasadena Gastroenterology Assoc, dba Digestive Health Center
- Office Based Practitioner
- Advanced Research Institute
- Advanced Research Institute
- Advanced Research Institute
- Advanced Research Institute
- New River Valley Research Institute
- Blue Ridge Medical Center
- Ramstad Medical Associates
- Aurora Wilkinson Medical Clinic
- Hepato-Gastroenterology HK s.r.o.
- Nemocnice Valasske Mezirici a.s.
- Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin
- Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen
- Haus der Gesundheit
- Praxis für Gastroenterologie und fachärztliche Innere Medizin
- Medizinische Fakultät der Otto-von-Guericke Universität
- Gemeinschaftspraxis Dres. Brandt
- Gemeinschaftspraxis Dres Josef und Wilma Großkopf
- Daugavpils Regional Hospital
- Pauls Stradins Clinical University Hospital
- Digestive Disease Centre "Gastro"
- Vidzemes Hospital
- NZOZ Specjalistyczne Centrum Gastrologii Gastromed
- Centrum Medyczne im Swietego Lukasza Sp. z o.o.
- NZOZ ''Salvia''
- Centrum Medyczne Szpital sw. Rodziny Sp. z o.o.
- Gastromed Sp. K. NZOZ
- Endoskopia Sp. z o.o.
- NZOZ Vivamed
- Lexmedica
- Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o.
- Brasov County Hospital
- Centrul Medical Galenus
- Cabinet Particular Policlinic Algomed SRL
- Policlinica "Dr. Citu" SRL
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)
SSP-002358 (0.5 mg) + PPI
SSP-002358 (2.0 mg) + PPI
Placebo + PPI
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
Secondary Outcome Measures
Change From Baseline in Heartburn-Free Days Over Weeks 5-8
Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8
PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358
Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Steady State Maximum Plasma Concentration (Cmax) of SSP-002358
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Time to Maximum Plasma Concentration (Tmax) of SSP-002358
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01472939
Brief Title
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Official Title
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) With Persistent Regurgitation With or Without Heartburn
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2012 (Actual)
Primary Completion Date
May 14, 2013 (Actual)
Study Completion Date
May 14, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)
Arm Type
Active Comparator
Arm Title
SSP-002358 (0.5 mg) + PPI
Arm Type
Active Comparator
Arm Title
SSP-002358 (2.0 mg) + PPI
Arm Type
Active Comparator
Arm Title
Placebo + PPI
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SSP-002358 (0.1 mg) + PPI
Other Intervention Name(s)
SPD557
Intervention Description
0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
Intervention Type
Drug
Intervention Name(s)
SSP-002358 (0.5 mg) + PPI
Intervention Description
0.5 mg tablet t.i.d. taken in addition to a PPI
Intervention Type
Drug
Intervention Name(s)
SSP-002358 (2.0 mg) + PPI
Intervention Description
2.0 mg tablet t.i.d. taken in addition to a PPI
Intervention Type
Drug
Intervention Name(s)
Placebo + PPI
Intervention Description
Placebo t.i.d. taken in addition to a PPI
Primary Outcome Measure Information:
Title
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
Time Frame
Baseline and over weeks 5-8
Secondary Outcome Measure Information:
Title
Change From Baseline in Heartburn-Free Days Over Weeks 5-8
Time Frame
Baseline and over weeks 5-8
Title
Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8
Description
PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.
Time Frame
Baseline and over weeks 5-8
Title
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358
Description
Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame
Over 8 hours post-dose (week 2 or later)
Title
Steady State Maximum Plasma Concentration (Cmax) of SSP-002358
Description
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Time Frame
Over 8 hours post-dose (week 2 or later)
Title
Time to Maximum Plasma Concentration (Tmax) of SSP-002358
Time Frame
Over 8 hours post-dose (week 2 or later)
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 Informed Consent Form signed voluntarily before the first study-related activity.
Aged between 18 and 70 years, inclusive.
Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)
Exclusion Criteria:
Subjects who show no response to heartburn while on PPI therapy.
Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
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, lung or neurologic disease, 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
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Preferred Research Partners, Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801-2417
Country
United States
Facility Name
Southern California Research Institute Medical Group Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Clinicos
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Medical Research Unlimited, LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Consultants for Clinical Research of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
S & W Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Medical Research Unlimited, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Jupiter Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Pines Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Radiant Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Gastrointestinal Specialists of GA, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Digestive Research Associates
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Rockford Gastroenterology Associates, Ltd
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Research Integrity
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Meritus Medical Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Beacon Clinical Research
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Center for Digestive and Liver Diseases
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Clinical Research Group of Montana
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
New Jersey Physicians, LLC
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
Facility Name
UNC Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Research Associates
City
Davidson
State/Province
North Carolina
ZIP/Postal Code
28036
Country
United States
Facility Name
Cumberland Research Associates
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28314
Country
United States
Facility Name
Vital Research, Inc.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Carolinas Research Associates
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Family Medical Associates
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Guthrie Clinic, Ltd.
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Meridian Clinical Research
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Clinsearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Radiant Research Dallas-North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
GI Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Pasadena Gastroenterology Assoc, dba Digestive Health Center
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77505
Country
United States
Facility Name
Office Based Practitioner
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Advanced Research Institute
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Advanced Research Institute
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Blue Ridge Medical Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Ramstad Medical Associates
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Facility Name
Aurora Wilkinson Medical Clinic
City
Summit
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Hepato-Gastroenterology HK s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
Nemocnice Valasske Mezirici a.s.
City
Valasske Mezirici
ZIP/Postal Code
75742
Country
Czechia
Facility Name
Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin
City
Bohlen
ZIP/Postal Code
4564
Country
Germany
Facility Name
Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen
City
Garmisch Partenkirchen
ZIP/Postal Code
82467
Country
Germany
Facility Name
Haus der Gesundheit
City
Ludwigshafen
ZIP/Postal Code
67067
Country
Germany
Facility Name
Praxis für Gastroenterologie und fachärztliche Innere Medizin
City
Ludwigshafen
ZIP/Postal Code
67067
Country
Germany
Facility Name
Medizinische Fakultät der Otto-von-Guericke Universität
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Brandt
City
Potsdam
ZIP/Postal Code
14482
Country
Germany
Facility Name
Gemeinschaftspraxis Dres Josef und Wilma Großkopf
City
Wallerfing
ZIP/Postal Code
94574
Country
Germany
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Digestive Disease Centre "Gastro"
City
Riga
ZIP/Postal Code
1006
Country
Latvia
Facility Name
Vidzemes Hospital
City
Valmiera
ZIP/Postal Code
4201
Country
Latvia
Facility Name
NZOZ Specjalistyczne Centrum Gastrologii Gastromed
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Centrum Medyczne im Swietego Lukasza Sp. z o.o.
City
Czestochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
NZOZ ''Salvia''
City
Katowice
ZIP/Postal Code
40-772
Country
Poland
Facility Name
Centrum Medyczne Szpital sw. Rodziny Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Gastromed Sp. K. NZOZ
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
NZOZ Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
ZIP/Postal Code
53-025
Country
Poland
Facility Name
Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
54-239
Country
Poland
Facility Name
Brasov County Hospital
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Centrul Medical Galenus
City
Targu-Mures
ZIP/Postal Code
540098
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed SRL
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Policlinica "Dr. Citu" SRL
City
Timisoara
ZIP/Postal Code
300594
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
25693609
Citation
Shaheen NJ, Adler J, Dedrie S, Johnson D, Malfertheiner P, Miner P, Meulemans A, Poole L, Tack J, Thielemans L, Troy S, Vakil N, Zerbib F, Ruth M. Randomised clinical trial: the 5-HT4 agonist revexepride in patients with gastro-oesophageal reflux disease who have persistent symptoms despite PPI therapy. Aliment Pharmacol Ther. 2015 Apr;41(7):649-61. doi: 10.1111/apt.13115. Epub 2015 Feb 19.
Results Reference
derived
Learn more about this trial
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
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