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Topical Formulations of Liposomal Local Anesthetics

U

University of Campinas, Brazil

Status and phase

Completed
Phase 1

Conditions

Administration, Topical Drug
Anesthetic Drugs
Administration, Topical

Treatments

Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01054547
093/2006

Details and patient eligibility

About

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

Full description

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.

Enrollment

80 patients

Sex

All

Ages

18 to 43 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

Liposomal ropivacaine, topical
Placebo Comparator group
Description:
The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa.
Treatment:
Drug: Ropivacaine
Drug: Ropivacaine
Liposomal ropivacaine, palatal mucosa
Placebo Comparator group
Description:
Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution.
Treatment:
Drug: Ropivacaine
Drug: Ropivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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