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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SW17 0QT
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55404
    Status
    Will Be Recruiting
    Contact us

    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
    Study complete
    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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