Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

November 14, 2005

Primary Completion Date

September 21, 2006

Study Completion Date

September 21, 2006

Conditions
Restless Legs SyndromeRestless Legs Syndrome (RLS)
Interventions
DRUG

Ropinirole IR 1 mg

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.

DRUG

Ropinirole IR 2 mg

Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.

DRUG

Ropinirole IR 1 mg Placebo

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.

DRUG

Ropinirole IR 2 mg Placebo

Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

DRUG

Ropinirole CR 2 mg

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.

DRUG

Ropinirole CR 3 mg

Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.

DRUG

Ropinirole CR 2 mg Placebo

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.

DRUG

Ropinirole CR 3 mg Placebo

Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.

Trial Locations (30)

10021

GSK Investigational Site, New York

11803

GSK Investigational Site, Plainview

27834

GSK Investigational Site, Greenville

29201

GSK Investigational Site, Columbia

30342

GSK Investigational Site, Atlanta

33486

GSK Investigational Site, Boca Raton

33609

GSK Investigational Site, Tampa

33701

GSK Investigational Site, St. Petersburg

46432

GSK Investigational Site, Dayton

48025

GSK Investigational Site, Bingham Farms

53715

GSK Investigational Site, Madison

60523

GSK Investigational Site, Oak Brook

66214

GSK Investigational Site, Lenexa

70808

GSK Investigational Site, Baton Rouge

73112

GSK Investigational Site, Oklahoma City

75213

GSK Investigational Site, Dallas

78229

GSK Investigational Site, San Antonio

82653

GSK Investigational Site, Laguna Hills

89119

GSK Investigational Site, Las Vegas

91106

GSK Investigational Site, Pasadena

91355

GSK Investigational Site, Reseda

93030

GSK Investigational Site, Oxnard

97210

GSK Investigational Site, Portland

98405

GSK Investigational Site, Tacoma

99362

GSK Investigational Site, Walla Walla

01104

GSK Investigational Site, Springfield

03766

GSK Investigational Site, Lebanon

08003

GSK Investigational Site, Cherry Hill

08755

GSK Investigational Site, Toms River

97504-8456

GSK Investigational Site, Medford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00256854 - Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome) | Biotech Hunter | Biotech Hunter