Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Maxillary Procedures - Full Text View

Sponsored by:	Novalar Pharmaceuticals, Inc.
Information provided by:	Novalar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00309335

Purpose

This Phase 3 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the efficacy, pharmacodynamics, and safety of NV-101 administered as a submucosal injection following completion of a restorative or periodontal maintenance procedure requiring local anesthesia with an agent containing a vasoconstrictor. Local vasodilatation that results in more rapid clearance of the anesthetic is the proposed mechanism of action.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multicenter, Randomized, Blinded, Controlled Study of NV-101 for Efficacy, Pharmacodynamics and Safety in Dental Patients Undergoing Maxillary Procedures

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

Drug Information available for: Phentolamine Phentolamine mesylate

U.S. FDA Resources

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

Primary Outcome Measures:

to determine if NV-101 accelerates time to normal sensation of the upper lip compared to control, as measured by standardized palpation procedure

Secondary Outcome Measures:

to determine if NV-101 accelerates the time to STAR-7 score of zero, as measured by soft tissue anesthesia questionnaire
to determine if NV-101 accelerates the time to normal function, as measured by a functional assessment battery
to determine if NV-101 accelerates the time to normal sensation of the tongue, as measured by standardized palpation procedure
to characterize the pharmacodynamic profile of NV-101, as measured by onset and offset of treatment effect
to evaluate the safety and tolerability of NV-101

Estimated Enrollment:	240
Study Start Date:	February 2006
Estimated Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female greater than or equal to 12 years
Sufficiently healthy, as determined by the Investigator, to receive routine dental care
Requires a restorative procedure in the maxilla such as cavity preparation, restoration/filling, or crown or a periodontal maintenance procedure, such as teeth cleaning (non-surgical scaling and/or root planing) on the same side of the upper mouth
Requires one or two cartridges of local anesthesia administered by one of the following intraoral injection techniques:
- inferior alveolar nerve block;
- Gow-Gates nerve block;
- Vazirani-Akinosi block;
- mental-incisive block; or
- supraperiosteal injection.
Dental procedure is completed within 60 minutes of the first administration of local anesthetic
Normal upper lip sensations at baseline prior to administration of local anesthetic
Upper lip on the side of the procedure is numb (no feeling) at the completion of the dental procedure
Soft tissue anesthesia recovery score of zero prior to anesthetic
Functional Assessment Battery by subject and observer rating is normal prior to anesthetic
Negative urine pregnancy test at screening in all females of childbearing potential past menarche (includes all females except for those whose menstrual periods have not occured for greater than or equal to 1 year after menopause, who are surgically sterilized, or who had a hysterectomy)
Understands and gives written informed consent
Subjects 12 to 17 years of age give written assent and parent(s) or legal guardian(s) give written informed consent
Can communicate with the Investigator and study staff, and can understand and comply with the requirements of the protocol

Exclusion Criteria:

History or presence of any condition that contraindicates routine dental care
Requires more than two cartridges of local anesthetic (excluding supplemental injections) or use of nitrous oxide or sedatives to perform the scheduled dental procedure
Scheduled dental procedure takes greater than 60 minutes to complete
Unable to tolerate 1 liter of water over 5 hours
Concurrent conditions: any incapacitating medical condition (e.g. unstable angina, uncontrolled cardiac arrhythmias, uncontrolled hypertension, uncontrolled hyperthyroidism); significant infection or inflammatory process of the oral cavity.
Concomitant medications: use of an opioid or opioid-like analgesic (e.g. codeine, tramadol, pentazocine) within 24 hours prior to administration of anesthetic
Allergy or intolerance to lidocaine, articaine, prilocaine, mepivacaine, epinephrine, levonordefrin, sulfites, phentolamine, or topical benzocaine
Has used an 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)
Any condition which, in the opinion of the Investigator, increases the risk to the subject of participating in this study or decreases the likelihood of compliance with the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309335

Locations

United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

Novalar Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Athena Papas, DMD

Tufts University

More Information

No publications provided

Study ID Numbers:	NOVA 04-200
Study First Received:	March 30, 2006
Last Updated:	November 16, 2006
ClinicalTrials.gov Identifier:	NCT00309335 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novalar Pharmaceuticals, Inc.:

Soft Tissue Anesthesia (Numbness)

Study placed in the following topic categories:

Phentolamine
Neurotransmitter Agents
Adrenergic Agents
Hypesthesia
Anesthetics

Adrenergic Antagonists
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents

Additional relevant MeSH terms:

Phentolamine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Adrenergic Antagonists
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009