RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole

NCT ID: NCT00314860

Last Updated: 2016-10-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-12-31

Brief Summary

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Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks

Detailed Description

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Conditions

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Restless Legs Syndrome Restless Legs Syndrome (RLS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ropinirole Extended Release (XR)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic 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

* Signs of secondary RLS.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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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

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Countries

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United States Australia Austria Belgium Denmark France Germany Italy Netherlands Norway Spain Sweden United Kingdom

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 Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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101468/204

Identifier Type: -

Identifier Source: org_study_id

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