Last updated: 11/06/2018 23:44:30
A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
Trial description: A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Tompson D, Della Pasqua 0, 1343840 (GlaxoSmithKline, Harlow, Essex, United Kingdom). A Single-Blind, Placebo-Controlled, Forced-Titration Study of Ropinirole in RLS: Pharmacokinetic-Pharmacodynamic Relation- ships [668]. 6/12/2004: GlaxoSmithKline, Harlow Essex United Kingdom, 6/17/2004. College on Problems of Drug Dependence 2004 Annual Meeting and Satellite Conferences; San Juan; Puerto Rico. San Juan; Puerto Rico; 2004 Jun 12; c2004.
Tompson D, Della Pasqua O. A single-blind, placebo-controlled, forced-titration study of ropinirole in RLS: pharmacokinetic-pharmacodynamic relationships. Associated Professional Sleep Societies, Chicago, USA, Jun 5–10 2004. Sleep 2004; 27(abstract suppl): A298–9: 668
Tompson, D and Della, Pasqua O, 2681073 (GlaxoSmithKline, Harlow, Essex, United Kingdom). A Single-Blind, Placebo-Controlled, Forced-Titration Study of Ropinirole in RLS: Pharmacokinetic-Pharmacodynamic Relation-ships [668]. 6/5/2004: GlaxoSmithKline, Harlow Essex United Kingdom, 6/10/2004. 18th Annual Meeting of the Associated Professional Sleep Societies; Philadelphia, PA; USA. Philadelphia, PA; USA; 2004 Jun 5; c2004.
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
May 2002 to September 2002
Type
Not applicable
Phase
2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-27-09
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
Not applicable
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