RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
NCT ID: NCT00314860
Last Updated: 2016-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
568 participants
INTERVENTIONAL
2006-02-28
2006-12-31
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
Interventions
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ropinirole Extended Release (XR)
Eligibility Criteria
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Inclusion Criteria
* Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.
Exclusion Criteria
* Primary sleep disorder or movement disorder other than RLS.
* Unstable medical conditions.
* Inability to tolerate dopamine agonists or dopamine antagonists.
* Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
18 Years
79 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Sun City, Arizona, United States
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Anaheim, California, United States
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Burlingame, California, United States
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Long Beach, California, United States
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Newport Beach, California, United States
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Pasadena, California, United States
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Redondo Beach, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Winnetka, California, United States
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Boca Raton, Florida, United States
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Coeur d'Alene, Idaho, United States
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Springfield, Massachusetts, United States
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West Yarmouth, Massachusetts, United States
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Worcester, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Saint Paul, Minnesota, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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Tabor City, North Carolina, United States
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Fargo, North Dakota, United States
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Oklahoma City, Oklahoma, United States
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Warwick, Rhode Island, United States
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Burlington, Vermont, United States
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Camperdown, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Kippa-Ring, Queensland, Australia
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Innsbruck, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Charleroi, , Belgium
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Edegem, , Belgium
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Liège, , Belgium
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Glostrup Municipality, , Denmark
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Hvidovre, , Denmark
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Koebenhavn NV, , Denmark
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Odense C, , Denmark
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Anzin, , France
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Bordeaux, , France
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Bron, , France
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Créteil, , France
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Grenoble, , France
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Lille, , France
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Montbrison, , France
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Nancy, , France
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Pessac, , France
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Munich, Bavaria, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Chemnitz, Saxony, Germany
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Köthen, Saxony-Anhalt, Germany
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Berlin, State of Berlin, Germany
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Gera, Thuringia, Germany
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Bologna, Emilia-Romagna, Italy
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Rome, Lazio, Italy
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Milan, Lombardy, Italy
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Pavia, Lombardy, Italy
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Pisa, Tuscany, Italy
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Amsterdam, , Netherlands
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Geldermalsen, , Netherlands
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Grubbenvorst, , Netherlands
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Hoogwoud, , Netherlands
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Nieuwegein, , Netherlands
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Roelofarendsveen, , Netherlands
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Zwolle, , Netherlands
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Bergen, , Norway
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Oslo, , Norway
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Sandvika, , Norway
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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San Sebastián, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Helsingborg, , Sweden
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Örebro, , Sweden
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Chesterfield, Derbyshire, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Frome, Somerset, United Kingdom
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Coventry, Warwickshire, United Kingdom
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Trowbridge, Wiltshire, United Kingdom
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Corsham, , United Kingdom
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Doncaster, , United Kingdom
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Ledbury, , United Kingdom
Countries
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Study Documents
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Document Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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101468/204
Identifier Type: -
Identifier Source: org_study_id
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