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NCT00650091 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
A Phase 3 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 3
- Development phase
- 264
- Enrollment target
NCT00650091: Completed Phase 3 study, sponsored by Duke University.
NCT00650091 is a Phase 3 study that has completed, run by Duke University. The registered enrollment target is 264 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650091, a Phase 3 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 264 participants
- Enrollment target
Study Summary
Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups - receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo - in a 1:1:1 ratio.
Primary Outcome
Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)
Interventions
- DRUG Placebo
- DRUG N-acetylcysteine (NAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT00650091 record still lists
NCT00650091 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00650091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00650091 about?
NCT00650091 is a clinical study titled "Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF". Idiopathic pulmonary fibrosis (IPF) is a long-term lung disease that affects an individual's ability to breathe. In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three group...
What is the current status of trial NCT00650091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2009-10. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00650091?
The interventions under investigation include: Placebo (DRUG), N-acetylcysteine (NAC) (DRUG).
Who is sponsoring clinical trial NCT00650091?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00650091's enrollment target sits among peer trials
264 1225th of 2000 higher than 773 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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