Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food - Tabular View

Tracking Information

First Received Date ^ICMJE

January 5, 2007

Last Updated Date

October 15, 2008

Start Date ^ICMJE

August 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration [ Time Frame: dosing interval ]

Original Primary Outcome Measures ^ICMJE

Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration

Change History

Complete list of historical versions of study NCT00419692 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: Time taken for ropinirole concentration to fall to half initial value ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

Official Title ^ICMJE

An Open Label, Repeat Dose, Dose Escalation Study Conducted in RLS Patients to Characterize Pharmacokinetics and Food Effect of Ropinirole Controlled Release for RLS

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 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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Restless Legs Syndrome (RLS)

Intervention ^ICMJE

Drug: Ropinirole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, South Africa

Administrative Information

NCT ID ^ICMJE

NCT00419692

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

ROR106470

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, PhD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP