Status:
COMPLETED
Safety and Efficacy Study of NV-101 in Dental Patients
Lead Sponsor:
Novalar Pharmaceuticals, Inc.
Conditions:
Soft Tissue Anesthesia (Numbness)
Eligibility:
All Genders
10-65 years
Phase:
PHASE2
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
Detailed Description
This was a randomized, double-blind, placebo-controlled, multi-center study. One hundred twenty-two patients aged 10-58 requiring treatment with one of four routine dental procedures were enrolled. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00154167
Start Date
February 1 2003
End Date
June 1 2003
Last Update
September 14 2005
Active Locations (1)
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1
Northwest Kinetics
Tacoma, Washington, United States, 98403