Local Anesthetics New Formulations: From Development to Clinical Tests

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01032798
First received: December 15, 2009
Last updated: January 19, 2010
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Local Anesthetic Effectiveness
Drug: mepivacaine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
Official Title: Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Latency period and duration of anesthesia were assessed by an electrical pulp tester [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentrations of mepivacaine [ Time Frame: 0 to 360 minutes after the injection ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2007
Study Completion Date: May 2008
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032798

Locations
Brazil
University of Campinas
Campinas, Sao Paulo, Brazil, 13083-970
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Eneida de Paula, PHD University of Campinas, Brazil
  More Information

No publications provided by University of Campinas, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Giovana R. Tofoli, UNICAMP
ClinicalTrials.gov Identifier: NCT01032798     History of Changes
Other Study ID Numbers: 06/00121-9
Study First Received: December 15, 2009
Last Updated: January 19, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Anesthetics, Local
Mepivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014