Local Anesthetics New Formulations: From Development to Clinical Tests

NCT ID: NCT01032798

Last Updated: 2010-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-05-31

Brief Summary

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

Detailed Description

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Conditions

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Local Anesthetic Effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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UNICAMP

Principal Investigators

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Eneida de Paula, PHD

Role: STUDY_DIRECTOR

University of Campinas, Brazil

Locations

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University of Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Tofoli GR, Cereda CM, Groppo FC, Volpato MC, Franz-Montan M, Ranali J, de Araujo DR, de Paula E. Efficacy of liposome-encapsulated mepivacaine for infiltrative anesthesia in volunteers. J Liposome Res. 2011 Mar;21(1):88-94. doi: 10.3109/08982104.2010.483596. Epub 2010 May 20.

Reference Type DERIVED
PMID: 20482446 (View on PubMed)

Other Identifiers

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06/00121-9

Identifier Type: -

Identifier Source: org_study_id

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