Safety and Efficacy Study of NV-101 in Dental Patients

NCT00154167 | Completed Phase 2

• 1 other identifier: NOVA 03-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was:

• to determine if NV-101 accelerates recovery from numbness compared to placebo
• to evaluate safety of NV-101

Conditions

Soft Tissue Anesthesia (Numbness)

Interventions

NV-101 (phentolamine mesylate solution) DRUG

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 10-65 years of age
• Body weight between 35 to 110 kg
• Healthy as determined by the Investigator based on medical history, physical examination, and 12 Lead ECG
• Clinical laboratory tests within the reference ranges or within clinically acceptable limits according to the Investigator
• Normal lip, nose, chin, and tongue sensations
• Women of childbearing potential must have agreed to use barrier contraception for the duration of the study (Women of childbearing potential included all women except for those who are premenstrual, whose menstrual periods have not occured for greater than or equal to one year after menopause, who are surgically sterilized, or who have had a hysterectomy)
• Can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol

You may not qualify if:

• Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue disease or disorder
• Clinically relevant surgical history
• History of alcoholism and/or drug abuse within the past 5 years
• Significant infection or known inflammatory process including viral infections
• Required prophylactic antibiotics for SBE (infectious endocarditis)
• Had acute gastrointestinal symptoms at screening and/or baseline
• Allergies to any of the following: lidocaine/epinephrine, articaine/epinephrine, prilocaine/epinephrine, bisulfites or metasulfites, or phentolamine
• Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
• Used pain relievers 24 hours prior to anesthetic administration
• Required the use of nitrous oxide or sedatives to perform the scheduled, eligible dental procedure
• Pregnancy, attempting to conceive,or lactating
• Used decongestants or other drugs with vasoactive moieties within 24 hours prior to anesthetic administration

Sponsors & Collaborators

• Novalar Pharmaceuticals, Inc.: lead

Study Sites (1)

Northwest Kinetics

Tacoma, Washington, 98403, United States

Location

MeSH Terms

Conditions

Hypesthesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Royce Morrison, MD

  Northwest Kinetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2003
• Study Completion: June 1, 2003
• Last Updated: September 14, 2005

Record last verified: 2005-09

Locations

US (1)