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NCT00116324 · ClinicalTrials.gov registry record · Phase 3
Predicting the Response to Montelukast by Genetic Variation in Asthmatics
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT00116324: Completed Phase 3 study, sponsored by Brigham and Women's Hospital.
NCT00116324 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116324, a Phase 3 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
The purpose of this study is to examine a specific variation in the genetic code for an enzyme (LTC4 synthase) which plays an important role in the airway inflammation associated with asthma. We hypothesize that asthmatic patients with this variant gene will have a better response to montelukast than patients with the wild type gene, as measured by the ability of montelukast to protect against a hypertonic saline challenge.
Interventions
- DRUG Montelukast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-04 |
| Est. Completion | 2006-12 |
| Phase | Phase 3 |
What the finished NCT00116324 record still lists
NCT00116324 is an interventional study that assigns participants to a tested intervention. The registered 150 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 (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Montelukast is the first listed.
NCT00116324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116324 about?
NCT00116324 is a clinical study titled "Predicting the Response to Montelukast by Genetic Variation in Asthmatics". The purpose of this study is to examine a specific variation in the genetic code for an enzyme (LTC4 synthase) which plays an important role in the airway inflammation associated with asthma. We hypothesize that asthmatic patients with this variant gene will have a better response to montelukast tha...
What is the current status of trial NCT00116324?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2003-04. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00116324?
The interventions under investigation include: Montelukast (DRUG).
Who is sponsoring clinical trial NCT00116324?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116324's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 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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