NCT01032798

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
Last Updated

January 20, 2010

Status Verified

April 1, 2007

First QC Date

December 15, 2009

Last Update Submit

January 19, 2010

Conditions

Local Anesthetic Effectiveness

Outcome Measures

Primary Outcomes (1)

  • Latency period and duration of anesthesia were assessed by an electrical pulp tester

    10 minutes

Secondary Outcomes (1)

  • Plasma concentrations of mepivacaine

    0 to 360 minutes after the injection

Interventions

mepivacaineDRUG

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 Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13083-970, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 20482446DERIVED

MeSH Terms

Interventions

Mepivacaine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eneida de Paula, PHD

    University of Campinas, Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

May 1, 2007

Study Completion

May 1, 2008

Last Updated

January 20, 2010

Record last verified: 2007-04

Locations

BR(1)