Last updated: 11/04/2018 10:31:14

A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole

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GSK study ID
RRL103628
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Clinicaltrials.gov ID
NCT00422994
EudraCT ID
2005-006139-55
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-Label, Parallel-Group, Repeat-Dose Study to Investigate the Effects of End Stage Renal Disease and Haemodialysis on the Pharmacokinetics of Ropinirole (Study RRL103628)
Trial description: This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.

Timeframe: 24 hours at Week 1 and 3

SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when "on dialysis" & "off dialysis" in patients.

Timeframe: Up to Week 4

Secondary outcomes:

ECG: every other visit

Timeframe: Up to Week 6

Vital Signs: Each visit

Timeframe: Up to Week 6

Adverse Events: each visit

Timeframe: Up to Week 6

Clinical laboratory: every other visit

Timeframe: Up to Week 6

Interventions:
Drug: ropinirole dosing for up to 28 days
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
April 2006 to December 2006
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 79 years
Accepts healthy volunteers
Yes
  • Inclusion:
  • Patients and subjects between 18-79 years old.
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion:
  • Patients and subjects between 18-79 years old.
  • End stage renal patients who are consistently receiving dialysis for a minimum of 3.5 hours, three times per week, with hemodialysis blood flow rates of >200mL/min may be eligible to enter the study.
  • Patients must also have systolic blood pressure 100-190mmHg and diastolic blood pressure <120mmHg.
  • Healthy subjects must have systolic blood pressure 100-150mmHg. Exclusion:
  • Female subjects who are pregnant and/or breast-feeding must not participate in this study.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
London, United Kingdom, SW17 0QT
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Will Be Recruiting
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-07-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study RRL103628 can be found on the GSK Clinical Study Register.
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