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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004388-62 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI) | Active Comparator |
| |
| SSP-002358 (0.5 mg) + PPI | Active Comparator |
| |
| SSP-002358 (2.0 mg) + PPI | Active Comparator |
| |
| Placebo + PPI | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSP-002358 (0.1 mg) + PPI | Drug | 0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8 | Baseline and over weeks 5-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Heartburn-Free Days Over Weeks 5-8 | Baseline and 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States | ||
| Genova Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25693609 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + PPI | Placebo taken three times daily (TID) in addition to a PPI |
| FG001 | SSP-002358 0.1mg + PPI | 0.1 mg tablet taken TID in addition to a PPI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| SSP-002358 (0.5 mg) + PPI | Drug | 0.5 mg tablet t.i.d. taken in addition to a PPI |
|
| SSP-002358 (2.0 mg) + PPI | Drug | 2.0 mg tablet t.i.d. taken in addition to a PPI |
|
| Placebo + PPI | Drug | Placebo t.i.d. taken in addition to a PPI |
|
| Baseline and over weeks 5-8 |
| 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. | Over 8 hours post-dose (week 2 or later) |
| 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. | Over 8 hours post-dose (week 2 or later) |
| Time to Maximum Plasma Concentration (Tmax) of SSP-002358 | Over 8 hours post-dose (week 2 or later) |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72205 | United States |
| Preferred Research Partners, Inc | Little Rock | Arkansas | 72211 | United States |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | United States |
| Anaheim Clinical Trials | Anaheim | California | 92801-2417 | United States |
| Southern California Research Institute Medical Group Inc | Los Angeles | California | 90045 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Clinicos | Colorado Springs | Colorado | 80904 | United States |
| Connecticut Gastroenterology Institute | Bristol | Connecticut | 06010 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| Medical Research Unlimited, LLC | Aventura | Florida | 33180 | United States |
| Consultants for Clinical Research of South Florida | Boynton Beach | Florida | 33426 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| S & W Clinical Research | Fort Lauderdale | Florida | 33306 | United States |
| Medical Research Unlimited, LLC | Hialeah | Florida | 33012 | United States |
| Jupiter Research | Jupiter | Florida | 33458 | United States |
| Pines Clinical Research, Inc. | Pembroke Pines | Florida | 33028 | United States |
| Radiant Research | Pinellas Park | Florida | 33781 | United States |
| Accord Clinical Research, LLC | Port Orange | Florida | 32129 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Gastrointestinal Specialists of GA, PC | Marietta | Georgia | 30060 | United States |
| Digestive Research Associates | Newnan | Georgia | 30263 | United States |
| Rockford Gastroenterology Associates, Ltd | Rockford | Illinois | 61107 | United States |
| Professional Research Network of Kansas, LLC | Wichita | Kansas | 67203 | United States |
| Research Integrity | Owensboro | Kentucky | 42303 | United States |
| Clinical Trials Management | Metairie | Louisiana | 70006 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71103 | United States |
| Meritus Medical Center | Hagerstown | Maryland | 21742 | United States |
| Beacon Clinical Research | Brockton | Massachusetts | 02301 | United States |
| Center for Digestive and Liver Diseases | Mexico | Missouri | 65265 | United States |
| Clinical Research Group of Montana | Bozeman | Montana | 59718 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| New Jersey Physicians, LLC | Clifton | New Jersey | 07012 | United States |
| UNC Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Research Associates | Davidson | North Carolina | 28036 | United States |
| Cumberland Research Associates | Fayetteville | North Carolina | 28314 | United States |
| Vital Research, Inc. | Greensboro | North Carolina | 27408 | United States |
| Carolinas Research Associates | Harrisburg | North Carolina | 28075 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Oklahoma Foundation for Digestive Research Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Family Medical Associates | Levittown | Pennsylvania | 19056 | United States |
| Guthrie Clinic, Ltd. | Sayre | Pennsylvania | 18840 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Meridian Clinical Research | Dakota Dunes | South Dakota | 57049 | United States |
| Clinsearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Radiant Research Dallas-North | Dallas | Texas | 75231 | United States |
| GI Consultants, P.A. | Houston | Texas | 77034 | United States |
| Pasadena Gastroenterology Assoc, dba Digestive Health Center | Pasadena | Texas | 77505 | United States |
| Office Based Practitioner | San Antonio | Texas | 78229 | United States |
| Advanced Research Institute | Clinton | Utah | 84015 | United States |
| Advanced Research Institute | Logan | Utah | 84341 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Advanced Research Institute | Sandy City | Utah | 84094 | United States |
| New River Valley Research Institute | Christiansburg | Virginia | 24073 | United States |
| Blue Ridge Medical Center | Lynchburg | Virginia | 24502 | United States |
| Ramstad Medical Associates | Suffolk | Virginia | 23435 | United States |
| Aurora Wilkinson Medical Clinic | Summit | Wisconsin | 53066 | United States |
| Hepato-Gastroenterology HK s.r.o. | Hradec Králové | 50012 | Czechia |
| Nemocnice Valasske Mezirici a.s. | Valašské Meziříčí | 75742 | Czechia |
| Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin | Böhlen | 4564 | Germany |
| Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen | Garmisch-Partenkirchen | 82467 | Germany |
| Haus der Gesundheit | Ludwigshafen | 67067 | Germany |
| Praxis für Gastroenterologie und fachärztliche Innere Medizin | Ludwigshafen | 67067 | Germany |
| Medizinische Fakultät der Otto-von-Guericke Universität | Magdeburg | 39120 | Germany |
| Gemeinschaftspraxis Dres. Brandt | Potsdam | 14482 | Germany |
| Gemeinschaftspraxis Dres Josef und Wilma Großkopf | Wallerfing | 94574 | Germany |
| Daugavpils Regional Hospital | Daugavpils | 5417 | Latvia |
| Pauls Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| Digestive Disease Centre "Gastro" | Riga | 1006 | Latvia |
| Vidzemes Hospital | Valmiera | 4201 | Latvia |
| NZOZ Specjalistyczne Centrum Gastrologii Gastromed | Bialystok | 15-351 | Poland |
| Centrum Medyczne im Swietego Lukasza Sp. z o.o. | Częstochowa | 42-202 | Poland |
| NZOZ ''Salvia'' | Katowice | 40-772 | Poland |
| Centrum Medyczne Szpital sw. Rodziny Sp. z o.o. | Lodz | 90-302 | Poland |
| Gastromed Sp. K. NZOZ | Lublin | 20-607 | Poland |
| Endoskopia Sp. z o.o. | Sopot | 81-756 | Poland |
| NZOZ Vivamed | Warsaw | 03-580 | Poland |
| Lexmedica | Wroclaw | 53-025 | Poland |
| Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o. | Wroclaw | 54-239 | Poland |
| Brasov County Hospital | Brasov | 500326 | Romania |
| Centrul Medical Galenus | Târgu Mureş | 540098 | Romania |
| Cabinet Particular Policlinic Algomed SRL | Timișoara | 300002 | Romania |
| Policlinica "Dr. Citu" SRL | Timișoara | 300594 | Romania |
| FG002 | SSP-002358 0.5mg + PPI | 0.5 mg tablet taken TID in addition to a PPI |
| FG003 | SSP-002358 2.0mg + PPI | 2.0 mg tablet taken TID in addition to a PPI |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set was used which consisted of all randomized subjects who took at least 1 dose of investigational product. Three subjects did not receive investigational product, therefore n=477.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + PPI | Placebo taken three times daily (TID) in addition to a PPI |
| BG001 | SSP-002358 0.1mg + PPI | 0.1 mg tablet taken TID in addition to a PPI |
| BG002 | SSP-002358 0.5mg + PPI | 0.5 mg tablet taken TID in addition to a PPI |
| BG003 | SSP-002358 2.0mg + PPI | 2.0 mg tablet taken TID in addition to a PPI |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | All randomized subjects (n = 480) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8 | Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | Least Squares Mean | Standard Error | percentage of days | Baseline and over weeks 5-8 |
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| Secondary | Change From Baseline in Heartburn-Free Days Over Weeks 5-8 | Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | Least Squares Mean | Standard Error | percentage of days | Baseline and over weeks 5-8 |
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| Secondary | 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. | Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and over weeks 5-8 |
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| Secondary | 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. | Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded. | Posted | Mean | Standard Deviation | pg*h/ml | Over 8 hours post-dose (week 2 or later) |
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| Secondary | 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. | Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded. | Posted | Mean | Standard Deviation | pg/ml | Over 8 hours post-dose (week 2 or later) |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of SSP-002358 | Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded. | Posted | Median | Full Range | hours | Over 8 hours post-dose (week 2 or later) |
|
|
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Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product (n = 477).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + PPI | Placebo taken three times daily (TID) in addition to a PPI | 0 | 122 | 25 | 122 | ||
| EG001 | SSP-002358 0.1mg + PPI | 0.1 mg tablet taken TID in addition to a PPI | 0 | 119 | 22 | 119 | ||
| EG002 | SSP-002358 0.5mg + PPI | 0.5 mg tablet taken TID in addition to a PPI | 0 | 118 | 35 | 118 | ||
| EG003 | SSP-002358 2.0mg + PPI | 2.0 mg tablet taken TID in addition to a PPI | 1 | 118 | 45 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Upper respiratory tract infection | Infections and infestations |
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| Back pain | Musculoskeletal and connective tissue disorders |
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| Headache | Nervous system disorders |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000600233 | revexepride |
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| 41 - 50 |
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| 51 - 65 |
|
| >65 |
|
| Male |
|
| FRANCE |
|
| GERMANY |
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| HUNGARY |
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| LATVIA |
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| POLAND |
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| ROMANIA |
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| UNITED STATES |
|
| 0.062 |
| Mean Difference (Final Values) |
| 7.42 |
| 2-Sided |
| 95 |
| -0.378 |
| 15.212 |
| Superiority or Other (legacy) |
| Mixed Models Repeated Measures Analysis | 0.650 | Mean Difference (Final Values) | 1.83 | 2-Sided | 95 | -6.100 | 9.765 | Superiority or Other (legacy) |
| Counts |
|---|
| Participants |
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2.0 mg tablet taken TID in addition to a PPI
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