Local Anesthetics New Formulations: From Development to Clinical Tests

Local Anesthetic Effectiveness Clinical Trial

Official title:

Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032798
• Other study ID #: 06/00121-9
• Status: Completed
• Phase: Phase 1
• First received: December 15, 2009
• Last updated: January 19, 2010
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: April 2007
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Local Anesthetic Effectiveness

Intervention

Drug:
• mepivacaine
One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency period and duration of anesthesia were assessed by an electrical pulp tester		10 minutes	No
Secondary	Plasma concentrations of mepivacaine		0 to 360 minutes after the injection	No