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NCT00309361 · ClinicalTrials.gov registry record · Phase 3
Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Mandibular Procedures
A Phase 3 study of Anesthesia, Dental, sponsored by Novalar Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT00309361: Completed Phase 3 study of Anesthesia, Dental, sponsored by Novalar Pharmaceuticals.
NCT00309361 is a Phase 3 study of Anesthesia, Dental that has completed, run by Novalar Pharmaceuticals. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00309361, a Phase 3 study of Anesthesia, Dental, has completed, sponsored by Novalar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
This Phase 3 study is designed as a multicenter, randomized, blinded, controlled study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a submucosal injection following completion of a restorative or periodontal maintenance procedure requiring local anesthesia with an agent containing a vasoconstrictor. Local vasodilation that results in more rapid clearance of the anesthetic is the proposed mechanism of action.
Conditions Studied
Interventions
- DRUG Phentolamine Mesylate (NV-101)
Study Locations (1)
Massachusetts
- Tufts School of Dental Medicine - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2006-02 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
What the finished NCT00309361 record still lists
NCT00309361 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Anesthesia, Dental appearing as the primary indexed condition, and to 1 intervention - of which Phentolamine Mesylate (NV-101) is the first listed.
NCT00309361 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00309361 about?
NCT00309361 is a clinical study titled "Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Mandibular Procedures". This Phase 3 study is designed as a multicenter, randomized, blinded, controlled study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a submucosal injection following completion of a restorative or periodontal maintenance procedure requiring local anesthesia with an...
What is the current status of trial NCT00309361?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2006-02. Estimated completion is 2006-07.
What conditions does trial NCT00309361 study?
This clinical trial studies the following conditions: Anesthesia, Dental.
What interventions are being tested in trial NCT00309361?
The interventions under investigation include: Phentolamine Mesylate (NV-101) (DRUG).
Who is sponsoring clinical trial NCT00309361?
This trial is sponsored by Novalar Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00309361 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00309361's enrollment target sits among peer trials
240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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