drugset / Trial / NCT00309322
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
RandomizedSingle-groupSingle-blindTreatment
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.
Timeline
- Start
- 2006-03
- Primary completion
- —
- Completion
- 2006-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Phentolamine | Small molecule | — | Other |
Indications
No indication recorded.