Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis

PHASE3CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

June 30, 2011

Study Completion Date

August 31, 2011

Conditions
Cystinosis
Interventions
DRUG

Cystagon® (Cysteamine Bitartrate)

"Run-in Period (Weeks 1, 2, 3) and Period 1 (Weeks 4, 5, 6) or Period 2 (Weeks 7, 8, 9); Immediate crossover to opposite treatment than taken during Period 1:~Every 6H, supplied in 150 and 50mg capsules/Duration of Treatment: 3 weeks each period used"

DRUG

Cysteamine Bitartrate Delayed-release Capsules (RP103)

"Period 1 (Weeks 4, 5, 6) or Period 2 (Weeks 7, 8, 9); Immediate crossover to opposite treatment than taken during Period 1:~Every 12H, supplied in 75 and 25mg capsules/Duration of Treatment: 3 weeks"

Trial Locations (8)

30322

Emory Children's Center, Atlanta

60614

Ann & Robert H. Lurie Children's Hospital of Chicago (formerly Children's Memorial Hospital), Chicago

94305

Stanford University Medical School, Stanford

Unknown

Hospices Civils de Lyon, Lyon

Villeneuve-Lapeyronie Hospital, Montpellier

Necker Hospital, Paris

Robert Debre Hospital, Paris

Radboud University Nijmegen Medical Center, Nijmegen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY