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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021397-12 | EudraCT Number |
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This study was terminated early due to recruitment difficulties. There were no safety concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD557 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD557 | Drug | 0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks | Baseline and 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. |
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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 |
|---|---|---|---|---|---|---|
| CUB Hôpital Erasme | Brussels | Brussels Capital | 1070 | Belgium | ||
| Cliniques universitaires Saint Luc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25530111 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD557 | 0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment |
| FG001 | Placebo | Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Drug |
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment |
|
| Baseline and 4 weeks |
| Brussels |
| 1200 |
| Belgium |
| UZ Leuven, Belgium | Leuven | 3000 | Belgium |
| CHU de Bordeaux - Hôpital Saint André | Bordeaux | 33075 | France |
| CHU de Lyon - Groupement Hospitalier Edouard Herriot | Lyon | 69437 | France |
| Hôtel Dieu - CHU de Nantes | Nantes | 44093 | France |
| Klinikum Garmisch-Partenkirchen GmbH | Garmisch-Partenkirchen | 82467 | Germany |
| Otto-von-Guericke University | Magdeburg | 39120 | Germany |
| Academisch Medisch Centrum (AMC) | Amsterdam | 1105 AZ | Netherlands |
| Inselspital Bern (Bern University Hopsital) | Bern | BHH D140 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| University Hospital Zurich | Zurich | CH-8091 | Switzerland |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Wingate Institute of Neurogastroenterology | London | E12AJ | United Kingdom |
| Queen's Medical Center (Nottingham University Hospital) | Nottingham | NG7 2UH | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Population was used defined as all subjects randomized into the study with at least 1 administration of the investigational product. Two subjects never received investigational product (n = 65).
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| ID | Title | Description |
|---|---|---|
| BG000 | SPD557 | 0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment |
| BG001 | Placebo | Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | All randomized subjects (n = 67). | 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 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. | Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment. | Posted | Mean | Standard Deviation | Number of Reflux Events | Baseline and 4 weeks |
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| Secondary | Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks | Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment. | Posted | Mean | Standard Deviation | Number of days | Baseline and 4 weeks |
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| Secondary | 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. | Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 4 weeks |
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The Safety Population was defined as all subjects randomized into the study with at least 1 administration of the investigational product. Two subjects never received investigational product (n = 65).
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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 | SPD557 | 0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment | 0 | 34 | 25 | 34 | ||
| EG001 | Placebo | Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment | 0 | 31 | 16 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
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| Abdominal pain | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Abdominal pain upper | Gastrointestinal disorders |
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| Dyspepsia | Gastrointestinal disorders |
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| Abdominal distension | Gastrointestinal disorders |
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| Headache | Nervous system disorders |
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| Dizziness | Nervous system disorders |
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| Influenza | Infections and infestations |
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| Nasopharyngitis | Infections and infestations |
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| Pharyngitis | Infections and infestations |
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| Edema peripheral | General disorders |
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Results data should be interpreted with caution since the study's early termination affects the statistical power to detect true differences between treatment groups.
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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| Male |
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| Belgium |
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| Netherlands |
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| Germany |
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| United Kingdom |
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| Switzerland |
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