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Trial: NCT01000961 [RDF]

Label NCT01000961
Slug nct01000961
Trialid NCT01000961
Lookup name NCT01000961
Provenance http://clinicaltrials.gov/show/NCT01000961?displayxml=true
Lastchanged date June 10, 2015
Firstreceived results date November 2, 2012
Firstreceived date October 22, 2009
Id info nct id NCT01000961
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment 43
Number of arms 2
Is section 801 Yes
Is fda regulated Yes
Brief title Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
Acronym
Official title A Randomized, Crossover Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients With Nephropathic Cystinosis
Study type Interventional
Id info nct alias
Completion date August 2011
Verification date June 2015
Why stopped
Id info org study id RP103-03
Required header url https://clinicaltrials.gov/show/NCT01000961
Study design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Source Raptor Pharmaceuticals Inc.
Primary completion date June 2011
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 07, 2016
Phase Phase 3
Start date June 2010
Has expanded access No
Biospec descr
Detailed description This is a multi-center, open-label, randomized, cross-over study to determine whether steady-state, twice a day treatment with Cysteamine Bitartrate Delayed-release Capsules(RP103) results in comparable depletion of white blood cell (WBC) cystine levels compared to the existing four times a day cysteamine treatment. It will involve up to 20 clinic visits plus intermittent home use of the RP103. Most of these clinic visits occur in clusters of 3-4 consecutive days. Eligible patients will be offered enrollment into a long-term follow up study.
Condition browse fa7de0b8a7647ce7e5535a1c5a18a3b3
Intervention browse 5e1d6a8badcf762913725c1870457d29
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group 15fef5da949b1f3ee3c801effc6aae7f
Oversight info United States: Food and Drug Administration (Oversight_info)
Eligibility 27c6bf276ca6774f91d47d5737775bc0
Keywords CTNS protein, human, cysteamine, cystinosis, inheritable disease, metabolic disease, nephropathic cystinosis, orphan disease
Conditions Cystinosis
Locations 1e27f22d1e554df3c35550a21d4c5305, 2530a4775c879911be256bdca9f76482, 41ffab5310276e56bf81b77fd5664ea2, 42ed49299d9c4d99a4f2a1c5bdb8ef2b, 4d89c8940f94c54bd366c1750e28fb50, 6dfd4ed3ebac2d8f04c6909fe869e85e, 89534bbcddb20246fa2b6d1d4f7d7fdc, f6a2b962c7473010a8de7e1d41df3726
Links http://www.procysbi.com
Results references None
Arm groups RP103 Q12H (Arm Group), Cystagon® Q6H (Arm Group)
Location countries France, Netherlands, United States
Interventions Cysteamine Bitartrate Delayed-release Capsules (RP103) (Intervention), Cystagon® (Cysteamine Bitartrate) (Intervention)
Secondary outcomes 36cc874a5d5d1f8c2c2afc3d42c21e4b, 4339138d88e02f61d64ddcf1466e5436, f8db8b16e1c929680d3c3f64a040c6fb
References PMID:16252107, PMID:16769383, PMID:17229040
Primary outcomes 9d446f3c6f10d14c94e5e37621476acf
Removed countries None
Overall officials 5fdb8c51f7e7ea68d9413714a9d05d9d