Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures

Anesthesia, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309322
• Other study ID #: NOVA 05-PEDS
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2006
• Last updated: November 16, 2006
• Start date: March 2006
• Est. completion date: August 2006

Study information

• Verified date: November 2006
• Source: Novalar Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

• Male or female, 4 to 11 years of age

• Sufficiently healthy, as determined by the Investigator, to receive routine dental care

• Requires a restorative procedure such as cavity preparation, or such as teeth cleaning (non-surgical scaling and/or root planing) in a single quadrant of the mouth

• Requires local anesthesia with 2% lidocaine with 1:100,000 epinephrine administered by submucosal injection

• Dental procedure(s) completed with 60 minutes of injection of local anesthetic

• Can be trained to complete the Wong Baker Pain Rating Scale

• For subjects 6 to 11 years of age who are trainable in standardized palpation procedure:

• have normal lip sensation at baseline prior to administration of local anesthetic

• have numbness of the relevant lip quadrant at completion of the dental procedure

• Negative urine pregnancy test at screening in female subjects who are past menarche

• Subjects give written or verbal assent, as applicable, and parents(s) or legal guardian(s) give written informed consent

Exclusion Criteria:

• Weight less than 15 kg

• History or presence of any condition that contraindicates routine dental care or use of local anesthetic

• Requires more than half cartridge of local anesthetic if weight is greater than or equal to 15 kg and less than 30 kg and more than one cartridge of local anesthetic if weight is greater than or equal to 30 kg, excluding supplemental injections

• Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, or topical benzocaine

• Has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration

• Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)

• Use of opioid-like analgesics within 24 hours prior to administration of local anesthetic

• Requires the use of local anesthetic other than lidocaine/epinephrine to perform the scheduled dental procedure

• Requires the use of nitrous oxide or sedatives to perform the scheduled dental procedure

• Any condition which, in the opinion of the Investigator, increases the risk to the subject of participating in the study or decreases the likelihood of compliance with the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Dental

Intervention

Drug:
• Phentolamine Mesylate (NV-101)

Locations

Country	Name	City	State
United States	The Forsyth Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novalar Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(All subjects) to evaluate the safety and tolerability of NV-101 as measured by: incidence, severity of adverse events
Primary	incidence, severity and duration of intraoral pain as measured by Wong Baker Pain Rating Scale
Primary	clinically significant changes in vital signs
Primary	clinically significant changes in oral cavity assessments
Primary	analgesics required for intraoral pain
Secondary	(For subjects 6 to 11 years of age who are trainable in standardized palpation procedure): to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure
Secondary	for mandibular procedures, to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure