Formulations of Liposomal Local Anesthetics | NCT01307969

Studies
Formulations of Liposomal Local Anesthetics

NCT01307969

Sponsor

University of Campinas, Brazil

Status

Completed

Last Update Posted

Mar 3, 2011Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Underdosing of Local Anesthetics, Initial Encounter

Interventions

Ropivacaine

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

May 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Feb 16, 2011

First Submission Date that Met QC Criteria

Mar 2, 2011

First Posted Date

Mar 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2011

Last Update Posted Date

Mar 3, 2011Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.

Detailed Description

This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anesthetic efficacy	Experimental	Local anesthetics were injected at the apex of the maxillary right canine.	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.	Anesthetic efficacy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
After anesthetic injection the pulpal response was assessed by an electrical pulp tester.		100 minutes

Secondary Outcomes

Measure	Description	Time Frame
Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.		240 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michelle Franz-Montan, PhD	Researcher at Unicamp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Piracicaba Dental School		Piracicaba	São Paulo		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21831487	Derived	Franz-Montan M, de Paula E, Groppo FC, Ranali J, Volpato MC. Efficacy of liposome-encapsulated 0.5% ropivacaine in maxillary dental anaesthesia. Br J Oral Maxillofac Surg. 2012 Jul;50(5):454-8. doi: 10.1016/j.bjoms.2011.07.010. Epub 2011 Aug 9.

ID	Term
D000077212	Ropivacaine
D008081	Liposomes
D004837	Epinephrine
D008012	Lidocaine

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds