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NCT00588016 · ClinicalTrials.gov registry record · Phase 1

Concentration of Itraconazole Solution in Nasal Secretions

A Phase 1 study of Sinusitis, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target
1
Study location

NCT00588016 is a Phase 1 study of Sinusitis that has completed, run by Mayo Clinic. The registered enrollment target is 6 participants, below the 130-participant average among 12 other Sinusitis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00588016, a Phase 1 study of Sinusitis, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target
1
Study location

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

FieldValue
Enrollment Target 6 participants
Start Date 2007-04
Est. Completion 2013-12
Phase Phase 1

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT00588016

The ClinicalTrials.gov registry entry for NCT00588016 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 12 other Sinusitis trials with a reported enrollment target (95% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

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.

NCT00588016 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

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.

What interventions are being tested in trial NCT00588016?

The interventions under investigation include: Itraconazole (DRUG).

Who is sponsoring clinical trial NCT00588016?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.