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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00996944 |
Purpose
This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic restless legs syndrome associated with Chronic kidney disease (CKD) managed with haemodialysis (including haemofiltration and haemodiafiltration) (hereinafter referred to as "uRLS"), to evaluate the efficacy and safety of long-term administration of ropinirole IR tablets, and assess the effect on the steady state pharmacokinetics in the long-term administration period of ropinirole IR tablets.
| Condition | Intervention | Phase |
|---|---|---|
|
Restless Legs Syndrome |
Drug: Ropinirole immediate release (IR) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration) |
| Enrollment: | 34 |
| Study Start Date: | November 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ropinirole IR |
Drug: Ropinirole immediate release (IR)
Subjects completing the screening period will be randomized (1:1) to receive the IR or placebo for 12 weeks. The treatment will be started at the initial dose of 0.25 mg/day within 1 to 3 hours before bedtime. The maximum available dose is 3 mg/day. For all subjects completing short-term period and entering the long-term treatment period, the open-label treatment will be started from IR 0.25 mg/ day regardless of dose levels during short-term period. The dose will be upward titrated from 0.25 mg/day to 0.5 mg/day and after that in increments of 0.5 mg/day until sufficient efficacy is obtained (targeting "much improved" or "very much improved" in the CGI-I) without safety/tolerability problem.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Subjects completing the screening period will be randomized (1:1) to receive the IR or placebo for 12 weeks. The treatment will be started at the initial dose of 0.25 mg/day within 1 to 3 hours before bedtime.
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
at Week -1 (at the screening visit)
Is of non-childbearing potential or Is of child-bearing potential, is not lactating and agrees to use one of GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy: abstinence, oral contraceptives, either combined or progestogen alone (see "Permitted medications"), injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring (see "Permitted medications"), percutaneous contraceptive patches (see "Permitted medications"), intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label, male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject, double barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] plus spermicidal agent [foam/gel/film/cream/suppository]).
at Week 0 (at the start of the treatment period)
Exclusion Criteria:
at Week -1 (at the screening visit)
at Week 0 (start of the treatment period)
Contacts and Locations| Japan | |
| GSK Investigational Site | |
| Aichi, Japan, 453-8566 | |
| GSK Investigational Site | |
| Aichi, Japan, 440-0035 | |
| GSK Investigational Site | |
| Chiba, Japan, 289-2511 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 803-0844 | |
| GSK Investigational Site | |
| Hiroshima, Japan, 737-0131 | |
| GSK Investigational Site | |
| Hokkaido, Japan, 070-0030 | |
| GSK Investigational Site | |
| Hyogo, Japan, 670-0947 | |
| GSK Investigational Site | |
| Ibaraki, Japan, 300-0053 | |
| GSK Investigational Site | |
| Kagawa, Japan, 761-8026 | |
| GSK Investigational Site | |
| Miyagi, Japan, 981-0911 | |
| GSK Investigational Site | |
| Nagasaki, Japan, 850-0052 | |
| GSK Investigational Site | |
| Okinawa, Japan, 901-2132 | |
| GSK Investigational Site | |
| Okinawa, Japan, 904-2143 | |
| GSK Investigational Site | |
| Osaka, Japan, 547-0024 | |
| GSK Investigational Site | |
| Shizuoka, Japan, 424-0012 | |
| GSK Investigational Site | |
| Tokushima, Japan, 770-0011 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00996944 History of Changes |
| Other Study ID Numbers: | 113079 |
| Study First Received: | October 8, 2009 |
| Results First Received: | February 10, 2011 |
| Last Updated: | October 13, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
ropinirole haemodialysis restless legs syndrome |
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Restless Legs Syndrome Psychomotor Agitation Urologic Diseases Renal Insufficiency Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations |
Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |