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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: Completed Phase 1 study of Sinusitis, sponsored by Mayo Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT00588016 record still lists
NCT00588016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 130-participant average among 12 other Sinusitis trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sinusitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00588016's enrollment target sits among peer trials
6 13th of 12 the lowest of 12 other Sinusitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sinusitis 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.
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