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NCT00570349 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis
A Phase 1 study of Cystic Fibrosis, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00570349 is a Phase 1 study of Cystic Fibrosis that has completed, run by Mallinckrodt. The registered enrollment target is 18 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00570349, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.
Conditions Studied
Interventions
- DRUG Nitrogen
- DRUG Nitric Oxide for Inhalation
Study Locations (1)
Colorado
- The Children's Hospital - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-07 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00570349
The ClinicalTrials.gov registry entry for NCT00570349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (90% lower). The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Nitrogen is the first listed.
NCT00570349 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT00570349 about?
NCT00570349 is a clinical study titled "Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis". The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expirat...
What is the current status of trial NCT00570349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2004-07. Estimated completion is 2008-12.
What conditions does trial NCT00570349 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT00570349?
The interventions under investigation include: Nitrogen (DRUG), Nitric Oxide for Inhalation (DRUG).
Who is sponsoring clinical trial NCT00570349?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00570349 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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