A Phase 2, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures

NCT00309322 Phase 2 COMPLETED

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.

Details

Lead sponsor	Novalar Pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	150
Start date	2006-03
Completion	2006-08

Conditions

• Anesthesia, Dental

Interventions

• Phentolamine Mesylate (NV-101)

Primary outcomes

• (All subjects) to evaluate the safety and tolerability of NV-101 as measured by: incidence, severity of adverse events
• incidence, severity and duration of intraoral pain as measured by Wong Baker Pain Rating Scale
• clinically significant changes in vital signs
• clinically significant changes in oral cavity assessments
• analgesics required for intraoral pain

Countries

United States