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NCT01136941 · ClinicalTrials.gov registry record · Phase 1
Trial of Zileuton CR in Children and Adults With Sickle Cell Disease
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01136941 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 9 participants.
The verdict
NCT01136941, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the safety of Zileuton and see what effects (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The investigators also want to see how Zileuton is handled by your body at different doses. Zileuton is a drug that is approved by the Food and Drug Administration (FDA) for the treatment of asthma for people age 12 and older. The FDA has not approved Zileuton for the treatment of SCD, so it is being studied as an investigational drug for SCD through an application to the FDA. In asthma patients, Zileuton helps by reducing inflammation. This study will see if Zileuton helps to reduce inflammation associated with SCD.
Interventions
- DRUG Zileuton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01136941
The ClinicalTrials.gov registry entry for NCT01136941 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zileuton is the first listed.
NCT01136941 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01136941 about?
NCT01136941 is a clinical study titled "Trial of Zileuton CR in Children and Adults With Sickle Cell Disease". The purpose of this research study is to test the safety of Zileuton and see what effects (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The investigators also want to see how Zileuton is handled by your body at different doses. Zileuton is a drug that is ap...
What is the current status of trial NCT01136941?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-09. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01136941?
The interventions under investigation include: Zileuton (DRUG).
Who is sponsoring clinical trial NCT01136941?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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