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NCT01733316 · ClinicalTrials.gov registry record · Phase 3
Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-Release Capsules (RP103) in Cystinosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT01733316 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 41 participants.
The verdict
NCT01733316, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to gather information about the effectiveness (how well it works to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103, compared to the already-approved drug cystinosis patients are taking called Cystagon®. In cystinosis, the body builds up cystine. When taken regularly, the active ingredient of Cystagon® (cysteamine bitartrate) reduces cystine in the body. RP103 has the same active ingredient as Cystagon® and is designed to reduce cystine in a similar way that Cystagon® does. To decide if RP103 is better than Cystagon®, the study will look at two types of blood tests. One test is pharmacodynamics (PD), which measures the amount of white blood cell (WBC) cystine after taking study drug. WBC cystine is a laboratory test used to find out if cysteamine bitartrate is reducing cystine levels in the body. The second test is pharmacokinetics (PK), which measures the amount of cysteamine in the blood after taking the drug. RP103 is different from Cystagon®: Instead of the cysteamine bitartrate being absorbed from the stomach, RP103 is designed to be absorbed from the small intestine. This may make the effects of the drug last longer, so that it can be taken twice a day instead of four times a day like Cystagon®. Some cystinosis patients have bad breath (halitosis) when they take Cystagon®. Study participants who experience bad breath with Cystagon® will be asked if they would like to participate in an optional "halitosis substudy" to investigate this issue by collecting some extra PK blood samples.
Interventions
- DRUG RP103
- DRUG Cystagon®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2017-07-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01733316
The ClinicalTrials.gov registry entry for NCT01733316 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RP103 is the first listed.
NCT01733316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01733316 about?
NCT01733316 is a clinical study titled "Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-Release Capsules (RP103) in Cystinosis". The purpose of this study is to gather information about the effectiveness (how well it works to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103, compared to the already-approved drug cystinosis patients are taking called Cystagon®. In cystinosis, the body builds up...
What is the current status of trial NCT01733316?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2013-01-31. Estimated completion is 2017-07-10.
What interventions are being tested in trial NCT01733316?
The interventions under investigation include: RP103 (DRUG), Cystagon® (DRUG).
Who is sponsoring clinical trial NCT01733316?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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