CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Cystagon® +1 moredrug
Likely dose
Cystagon® 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00872729
NCT00872729Phase 2Completed
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A Pilot Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cysteamine Bitartrate (Cystagon®) in Patients With Nephropathic Cystinosis

Amgen·interventional·Posted Mar 31, 2009·Updated Dec 19, 2024

In Brief

A Phase 2 clinical trial evaluating Cystagon® and RP103 for Cystinosis. Completed, enrolled 9 participants across 1 site.

Detailed Summary

Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystinosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2009
Enrollment StartMay 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.3 years ago

Interventions

Cystagon®drug

Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg. Duration of Treatment and Dose: Reference Period up to four doses Q6H.

RP103drug

Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg. Duration of treatment and Dose: Single dose of Test Product at dose equivalent to Reference Product.