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Concentration of Itraconazole Solution in Nasal Secretions
NCT00588016 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to determine the concentration of itraconazole irrigation in nasal mucous specimens via collection and High-performance liquid chromatography (HPLC) assay. Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be enrolled in the initial evaluation. After an initial control nasal specimen, followed by seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected at varying time intervals and the concentrations measured. The primary endpoint is development of a reliable collection and assay technique with concentration curves over time of topically administered itraconazole. A secondary endpoint is to determine if the concentrations measured achieve a mean inhibitory concentration (MIC90) to commonly cultured fungal species in the nose.
Conditions Studied
Interventions
- DRUG Itraconazole
Study Locations (1)
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00588016
The ClinicalTrials.gov registry entry for NCT00588016 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sinusitis appearing as the primary indexed condition, and to 1 intervention — of which Itraconazole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00588016 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00588016 about?
NCT00588016 is a clinical study titled "Concentration of Itraconazole Solution in Nasal Secretions". The primary objective of this study is to determine the concentration of itraconazole irrigation in nasal mucous specimens via collection and High-performance liquid chromatography (HPLC) assay. Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be enrolled in th...
What is the current status of trial NCT00588016?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2007-04. Estimated completion is 2013-12.
What conditions does trial NCT00588016 study?
This clinical trial studies the following conditions: Sinusitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00588016?
The interventions under investigation include: Itraconazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00588016?
This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00588016 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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