Trials / Completed
CompletedNCT00309322
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
A Phase 2, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (planned)
- Sponsor
- Novalar Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 11 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Phentolamine Mesylate (NV-101) |
Timeline
- Start date
- 2006-03-01
- Completion
- 2006-08-01
- First posted
- 2006-03-31
- Last updated
- 2006-11-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00309322. Inclusion in this directory is not an endorsement.