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NCT00262405 · ClinicalTrials.gov registry record · Phase 2
Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
A Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT00262405: Completed Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by University of Michigan.
NCT00262405 is a Phase 2 study of Idiopathic Pulmonary Fibrosis that has completed, run by University of Michigan. The registered enrollment target is 44 participants, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00262405, a Phase 2 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.
Conditions Studied
Interventions
- DRUG zileuton
- DRUG azathioprine/prednisone
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2001-01 |
| Est. Completion | 2007-05 |
| Phase | Phase 2 |
What the finished NCT00262405 record still lists
NCT00262405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which zileuton is the first listed.
NCT00262405 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT00262405 about?
NCT00262405 is a clinical study titled "Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis". Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms a...
What is the current status of trial NCT00262405?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2001-01. Estimated completion is 2007-05.
What conditions does trial NCT00262405 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT00262405?
The interventions under investigation include: zileuton (DRUG), azathioprine/prednisone (DRUG).
Who is sponsoring clinical trial NCT00262405?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00262405 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00262405's enrollment target sits among peer trials
44 34th of 51 higher than 18 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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