Status:
COMPLETED
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other pati...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with a diagnosis of RLS
- Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
- Normal blood pressure pre-study
- Light smokers only (\<20/day)
- Exclusion criteria:
- History of postural hypotension or faints
- Secondary RLS
- Patients who suffer from a primary sleep disorder other than RLS
- Patients diagnosed with movement disorders
- Patients with unstable medical conditions
- Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
- Patients with abnormal laboratory values
- Patients with hepatitis or HIV
- Patients who abuse alcohol or drugs
- Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa
Exclusion
Key Trial Info
Start Date :
August 24 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00419692
Start Date
August 24 2006
End Date
December 12 2006
Last Update
October 13 2017
Active Locations (2)
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1
GSK Investigational Site
Berlin, Germany, 14050
2
GSK Investigational Site
George, South Africa, 6530