Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
NCT ID: NCT00986245
Last Updated: 2013-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
82 participants
INTERVENTIONAL
2009-09-30
2010-12-31
Brief Summary
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2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged release
Detailed Description
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2. Cross over study design:
* Group 1: once daily dose for 2 month then into twice daily in divided dose for 2 months
* Group 2: twice daily in divided dose for 2 months then into once daily dose for 2 months
3. Dose adjustment may be done in the first 4 weeks.
4. Compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Ropinirole PR QD first, then BID
Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing
Ropinirole Prolonged release
Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Ropinirole PR BID first, and then QD
Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing
Ropinirole Prolonged release
Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Interventions
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Ropinirole Prolonged release
Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Parkinson disease
3. On dopamine agonists (Ropinirole IR or Pramipexole IR) and are considering to change into Ropinirole PR
4. On stable antiparkinsonian medication for at least 4 weeks
5. Who signed consent to the study
Exclusion Criteria
2. Who have dementia, psychosis, major depression and other serious neurological or medical problems
3. Who are allergic to the similar medications
4. Who has history of heavy metal poisoning
5. Who were on othe clinical trials of other medications within the last 4 weeks
6. Whoa re pregnant or lactating
7. Who are considered not eligible by the investigator
30 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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BS Jeon
Professor
Principal Investigators
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Beom S Jeon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Boramae City Hospital
Seoul, , South Korea
Countries
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References
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Lyons KE, Pahwa R. An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease. Mov Disord. 2009 Oct 30;24(14):2121-7. doi: 10.1002/mds.22750.
Stocchi F, Hersh BP, Scott BL, Nausieda PA, Giorgi L; Ease-PD Monotherapy Study Investigators. Ropinirole 24-hour prolonged release and ropinirole immediate release in early Parkinson's disease: a randomized, double-blind, non-inferiority crossover study. Curr Med Res Opin. 2008 Oct;24(10):2883-95. doi: 10.1185/03007990802387130. Epub 2008 Sep 2.
Yun JY, Kim HJ, Lee JY, Kim YE, Kim JS, Kim JM, Jeon BS. Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease. BMC Neurol. 2013 Sep 2;13:113. doi: 10.1186/1471-2377-13-113.
Other Identifiers
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0908-037-290
Identifier Type: -
Identifier Source: org_study_id