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Topical Formulations of Liposomal Local Anesthetics

NCT01054547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-01-22

No results posted yet for this study

Summary

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.

Conditions

  • Administration, Topical Drug
  • Administration, Topical
  • Anesthetic Drugs

Interventions

DRUG

Ropivacaine

100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.

DRUG

Ropivacaine

100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Campinas, Brazil

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2006-12-31
Completion
2007-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054547 on ClinicalTrials.gov