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NCT01304316 · ClinicalTrials.gov registry record · Phase 2
Dose-Escalation Safety and Pharmacokinetic Study of K305
A Phase 2 study of Anesthesia, sponsored by St. Renatus.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01304316: Completed Phase 2 study of Anesthesia, sponsored by St. Renatus.
NCT01304316 is a Phase 2 study of Anesthesia that has completed, run by St. Renatus. The registered enrollment target is 12 participants, below the 109,410-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01304316, a Phase 2 study of Anesthesia, has completed, sponsored by St. Renatus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline
Primary Outcome
Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group
Conditions Studied
Interventions
- DRUG Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Study Locations (1)
Pennsylvania
- University of Pennsylvania, School of Dental Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-09 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT01304316 record still lists
NCT01304316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 109,410-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Anesthesia appearing as the primary indexed condition, and to 1 intervention - of which Tetracaine HCl 3% and Oxymetazoline HCl 0.05% is the first listed.
NCT01304316 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01304316 about?
NCT01304316 is a clinical study titled "Dose-Escalation Safety and Pharmacokinetic Study of K305". The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline
What is the current status of trial NCT01304316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2010-09. Estimated completion is 2010-11.
What conditions does trial NCT01304316 study?
This clinical trial studies the following conditions: Anesthesia.
What interventions are being tested in trial NCT01304316?
The interventions under investigation include: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% (DRUG).
Who is sponsoring clinical trial NCT01304316?
This trial is sponsored by St. Renatus, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01304316 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anesthesia
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 NCT01304316's enrollment target sits among peer trials
12 56th of 57 higher than 1 of 57 other Anesthesia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anesthesia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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