Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
Information source: Novalar Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia, Dental
Intervention: Phentolamine Mesylate (NV-101) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novalar Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Mary Tavares, DDS, Principal Investigator, Affiliation: The Forsyth Institute
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Primary outcome: (All subjects) to evaluate the safety and tolerability of NV-101 as measured by: incidence, severity of adverse eventsincidence, 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
Secondary outcome: (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 procedurefor mandibular procedures, to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure
Eligibility
Minimum age: 4 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
The Forsyth Institute, Boston, Massachusetts 02115, United States
Additional Information
Starting date: March 2006
Last updated: November 16, 2006
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