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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 is a Phase 1 study that has completed, run by Insmed Incorporated. The registered enrollment target is 41 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00558844
The ClinicalTrials.gov registry entry for NCT00558844 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insmed Incorporated, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Arikayce™ 560 mg is the first listed.
NCT00558844 reports 0 study locations.
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.
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