Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome
Intervention: Ropinirole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, PhD, Principal Investigator, Affiliation: GlaxoSmithKline
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 patients following a high-fat breakfast), and to assess the difference in
absorption, distribution, metabolism and excretion of ropinirole if patients are given two
3mg ropinirole tablets versus one 6mg tablet.
Clinical Details
Official title: An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS
Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval
Ropinirole maximum plasma concentration
Secondary outcome: Time to attain the maximum plasma concentration
Time taken for ropinirole concentration to fall to half initial value
Incidence of adverse events
Vital signs, ECG and clinical laboratory data
As above, but for ropinirole metabolites
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
GSK Clinical Trials Call Centre, Berlin 14050, Germany
GSK Clinical Trials Call Centre, George 6530, South Africa
Additional Information
Starting date: September 2006
Last updated: September 4, 2007
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