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Sponsored by: |
Novalar Pharmaceuticals, Inc. |
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Information provided by: | Novalar Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00309361 |
This Phase 3 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 vasodilation that results in more rapid clearance of the anesthetic is the proposed mechanism of action.
Condition | Intervention | Phase |
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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 Mandibular Procedures |
Estimated Enrollment: | 240 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Requires one or two cartridges of local anesthesia administered by one of the following intraoral injection techniques:
Exclusion Criteria:
United States, Massachusetts | |
Tufts School of Dental Medicine | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Athena Papas, DMD | Tufts University |
Study ID Numbers: | NOVA 04-100 |
Study First Received: | March 30, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00309361 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Soft Tissue Anesthesia (Numbness) |
Phentolamine Neurotransmitter Agents Adrenergic Agents Hypesthesia Anesthetics |
Adrenergic Antagonists Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents |
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 |