An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients
NCT ID: NCT01370863
Last Updated: 2021-06-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
67 participants
INTERVENTIONAL
2010-12-02
2012-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPD557
SPD557
0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
Placebo
placebo
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
Interventions
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SPD557
0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
placebo
matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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CUB Hôpital Erasme
Brussels, Brussels Capital, Belgium
Cliniques universitaires Saint Luc
Brussels, , Belgium
UZ Leuven, Belgium
Leuven, , Belgium
CHU de Bordeaux - Hôpital Saint André
Bordeaux, , France
CHU de Lyon - Groupement Hospitalier Edouard Herriot
Lyon, , France
Hôtel Dieu - CHU de Nantes
Nantes, , France
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, , Germany
Otto-von-Guericke University
Magdeburg, , Germany
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Inselspital Bern (Bern University Hopsital)
Bern, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Addenbrooke's Hospital
Cambridge, , United Kingdom
Wingate Institute of Neurogastroenterology
London, , United Kingdom
Queen's Medical Center (Nottingham University Hospital)
Nottingham, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-021397-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD557-202
Identifier Type: -
Identifier Source: org_study_id
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