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Pramipexole Conversion to Ropinirole Controlled Release (CR)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Rajesh Pahwa, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00275275
First received: January 9, 2006
Last updated: July 21, 2012
Last verified: July 2012
History of Changes
Results First Received: May 2, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: Requip PR
Drug: Mirapex

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled at the University of Kansas Medical Center. Enrollment started in January 2006 and ended in February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mirapex to Requip 24-Hour of 1:3 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
Mirapex to Requip 24-Hour of 1:4 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
Mirapex to Requip 24-Hour of 1:5 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5

Participant Flow:   Overall Study
    Mirapex to Requip 24-Hour of 1:3     Mirapex to Requip 24-Hour of 1:4     Mirapex to Requip 24-Hour of 1:5  
STARTED     20     20     21 [1]
COMPLETED     14     18     15  
NOT COMPLETED     6     2     6  
[1] One participant was removed after enrollment and before any data was collected for him.



  Baseline Characteristics
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Reporting Groups
  Description
Mirapex to Requip 24-Hour of 1:3 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
Mirapex to Requip 24-Hour of 1:4 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
Mirapex to Requip 24-Hour of 1:5 Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
Total Total of all reporting groups

Baseline Measures
    Mirapex to Requip 24-Hour of 1:3     Mirapex to Requip 24-Hour of 1:4     Mirapex to Requip 24-Hour of 1:5     Total  
Number of Participants  
[units: participants]
 		  20     20     21     61  
Age  
[units: years]
Mean ± Standard Deviation 		  64.1  ± 10.1     63.9  ± 9.7     66.2  ± 9.7     64.7  ± 9.7  
Gender  
[units: participants]
 		       
Female     8     5     5     18  
Male     12     15     16     43  
Region of Enrollment  
[units: participants]
 		       
United States     20     20     21     61  



  Outcome Measures
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1.  Primary:   Adverse Effects Experienced   [ Time Frame: Week 4 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Dose Adjustments   [ Time Frame: Week 4 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Kelly E. Lyons, PhD
Organization: University of Kansas Medical Center
phone: 913-588-7159
e-mail: klyons@kumc.edu


No publications provided


Responsible Party: Rajesh Pahwa, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00275275     History of Changes
Other Study ID Numbers: 10161
Study First Received: January 9, 2006
Results First Received: May 2, 2012
Last Updated: July 21, 2012
Health Authority: United States: Food and Drug Administration