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NCT00558844 · ClinicalTrials.gov registry record · Phase 1
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
A Phase 1 study, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT00558844: Completed Phase 1 study, sponsored by Insmed Incorporated.
NCT00558844 is a Phase 1 study that has completed, run by Insmed Incorporated. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00558844, a Phase 1 study, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa.
Primary Outcome
To evaluate the safety and tolerability of 28 days of daily dosing of nebulized Arikayce™, liposomal amikacin for inhalation.
Interventions
- DRUG Arikayce™ 560 mg
- DRUG Placebo for 560 mg
- DRUG Arikayce™ 70 mg
- DRUG Arikayce™ 140 mg
- DRUG Placebo for 70 mg / 140 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
What the finished NCT00558844 record still lists
NCT00558844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 5 interventions - of which Arikayce™ 560 mg is the first listed.
NCT00558844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00558844 about?
NCT00558844 is a clinical study titled "Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa". This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa.
What is the current status of trial NCT00558844?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2008-01. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00558844?
The interventions under investigation include: Arikayce™ 560 mg (DRUG), Placebo for 560 mg (DRUG), Arikayce™ 70 mg (DRUG), Arikayce™ 140 mg (DRUG), Placebo for 70 mg / 140 mg (DRUG).
Who is sponsoring clinical trial NCT00558844?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00558844's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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