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NCT00309322 · ClinicalTrials.gov registry record · Phase 2
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
A Phase 2 study, sponsored by Novalar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00309322 is a Phase 2 study that has completed, run by Novalar Pharmaceuticals. The registered enrollment target is 150 participants.
The verdict
NCT00309322, a Phase 2 study, has completed, sponsored by Novalar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. NV-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental procedure(s) shall be performed in a single quadrant of the mouth and include cavity preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing), or crowns.
Interventions
- DRUG Phentolamine Mesylate (NV-101)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00309322
The ClinicalTrials.gov registry entry for NCT00309322 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novalar Pharmaceuticals, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Phentolamine Mesylate (NV-101) is the first listed.
NCT00309322 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00309322 about?
NCT00309322 is a clinical study titled "Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures". This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. NV-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesi...
What is the current status of trial NCT00309322?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2006-03. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00309322?
The interventions under investigation include: Phentolamine Mesylate (NV-101) (DRUG).
Who is sponsoring clinical trial NCT00309322?
This trial is sponsored by Novalar Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
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