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

This study has been completed.
Sponsor:
Information provided by:
Novalar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00309322
First received: March 30, 2006
Last updated: November 16, 2006
Last verified: November 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Anesthesia, Dental
 Drug: Phentolamine Mesylate (NV-101)
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novalar Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • (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

Secondary Outcome Measures:
  • (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
  • for mandibular procedures, to determine if NV-101 accelerates the time to normal tongue sensation as measured by standardized palpation procedure

Estimated Enrollment: 150
Study Start Date: March 2006
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309322

Locations
United States, Massachusetts
The Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Novalar Pharmaceuticals, Inc.
Investigators
Principal Investigator: Mary Tavares, DDS The Forsyth Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00309322     History of Changes
Other Study ID Numbers: NOVA 05-PEDS
Study First Received: March 30, 2006
Last Updated: November 16, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Novalar Pharmaceuticals, Inc.:
Soft Tissue Anesthesia (Numbness)

Additional relevant MeSH terms:
Phentolamine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013