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

Healthy Clinical Trial

Official title:

Uni Centric Study, Phase III, for Safety Oral Mucosa Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Canela Power

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687037
• Other study ID #: CPYRY_L_03930
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2008
• Last updated: February 12, 2009
• Start date: January 2008

Study information

• Verified date: February 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Integral buccal mucous (without oral pathologies);

• Normal odontological exams;

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;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Cetylpyridinium chloride

Locations

Country	Name	City	State
Brazil	Sanofi-aventis	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		21 days	Yes