Local Anesthetics New Formulations: From Development to Clinical Tests
Sponsor
University of Campinas, Brazil (Other)
Overall Status
Completed
CT.gov ID
NCT01032798
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
30
1
12
2.5
Study Details
Study Description
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 |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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 1, 2007
Actual Study Completion Date
:
May 1, 2008
Outcome Measures
Primary Outcome Measures
- Latency period and duration of anesthesia were assessed by an electrical pulp tester [10 minutes]
Secondary Outcome Measures
- Plasma concentrations of mepivacaine [0 to 360 minutes after the injection]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01032798
Other Study ID Numbers:
- 06/00121-9
First Posted:
Dec 16, 2009
Last Update Posted:
Jan 20, 2010
Last Verified:
Apr 1, 2007
Additional relevant MeSH terms: