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Local Anesthetics New Formulations: From Development to Clinical Tests

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032798
First Posted: December 16, 2009
Last Update Posted: January 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
  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: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Plasma concentrations of mepivacaine [ Time Frame: 0 to 360 minutes after the injection ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 15, 2009
First Posted: December 16, 2009
Last Update Posted: January 20, 2010
Last Verified: April 2007

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