Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01621685 · ClinicalTrials.gov registry record · Phase 1
Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men
A Phase 1 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01621685 is a Phase 1 study that has completed, run by University of South Florida. The registered enrollment target is 40 participants.
The verdict
NCT01621685, a Phase 1 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.
Interventions
- BIOLOGICAL biological/vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01621685
The ClinicalTrials.gov registry entry for NCT01621685 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which biological/vaccine is the first listed.
NCT01621685 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01621685 about?
NCT01621685 is a clinical study titled "Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men". In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Cap...
What is the current status of trial NCT01621685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-09. Estimated completion is 2007-09.
What interventions are being tested in trial NCT01621685?
The interventions under investigation include: biological/vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01621685?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.