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Local Anesthetics New Formulations: From Development to Clinical Tests

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ClinicalTrials.gov Identifier: NCT01032798
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil

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

Condition or disease Intervention/treatment Phase
Local Anesthetic Effectiveness Drug: mepivacaine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : May 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources


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.


Primary Outcome Measures :
  1. Latency period and duration of anesthesia were assessed by an electrical pulp tester [ Time Frame: 10 minutes ]

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


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

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

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 Posted: December 16, 2009    Key Record Dates
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