Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela Power

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00687037

Purpose

To prove the safety, in normal conditions, of the odontological use formulation of the product Cepacol Canela Power.

Condition	Intervention	Phase
Healthy	Drug: Cetylpyridinium chloride	Phase III

Drug Information available for: Chlorides Cetylpyridinium chloride Benzocaine

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Uni Centric Study, Phase III, for Safety Oral Mucosa Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Canela Power

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Patients will be evaluated according to the adverse reactions and the intensity of them. The volunteers will also answer a questionnaire about the physical attributes of the product. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	December 2007
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Cetylpyridinium chloride during 21 days.	Drug: Cetylpyridinium chloride

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Lactation or gestational risk or gestation;
Use of Anti-inflammatory or immunosuppression drugs 15 days before the study;
Being in odontological treatment;
Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results;
Personal history of allergic disease in the area to be treated;
Allergic or atopic history;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687037

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima, MD

Sanofi-aventis administrative office Brazil

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	CPYRY_L_03930
Study First Received:	May 27, 2008
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00687037
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Sanofi-Aventis:

oral hygiene

Study placed in the following topic categories:

Benzocaine
Cetylpyridinium
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009