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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00314860




Registration number
NCT00314860
Ethics application status
Date submitted
13/04/2006
Date registered
17/04/2006

Titles & IDs
Public title
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
Scientific title
A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)
Secondary ID [1] 0 0
101468/204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Restless Legs Syndrome 0 0
Restless Legs Syndrome (RLS) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.
Timepoint [1] 0 0
12 Weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
568
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [3] 0 0
GSK Investigational Site - Kippa Ring
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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Missouri
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Nevada
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New York
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North Carolina
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North Dakota
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Oklahoma
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Rhode Island
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United States of America
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Vermont
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Austria
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Innsbruck
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Liege
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Belgium
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Liège
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Denmark
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Glostrup
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Denmark
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Hvidovre
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Denmark
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Koebenhavn NV
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Denmark
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Odense C
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France
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Anzin
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France
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Bordeaux
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France
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Bron Cedex
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France
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Créteil
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France
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Grenoble Cedex 09
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France
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Lille
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France
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Montbrison
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France
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Nancy Cedex
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France
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Pessac Cedex
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Germany
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Bayern
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Germany
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Mecklenburg-Vorpommern
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Thueringen
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Germany
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Berlin
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Toscana
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Netherlands
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Amsterdam
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Netherlands
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Geldermalsen
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Netherlands
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Grubbenvorst
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Netherlands
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Hoogwoud
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Netherlands
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Nieuwegein
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Netherlands
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Roelofarendsveen
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Netherlands
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Zwolle
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Sandvika
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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San Sebastián
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Spain
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Zaragoza
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Sweden
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Göteborg
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Sweden
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Helsingborg
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Sweden
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Örebro
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United Kingdom
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Derbyshire
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United Kingdom
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Lancashire
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United Kingdom
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Somerset
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United Kingdom
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Warwickshire
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United Kingdom
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Wiltshire
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United Kingdom
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Corsham
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United Kingdom
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Doncaster
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United Kingdom
State/province [73] 0 0
Ledbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00314860