NCT00729599

Brief Summary

To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
Last Updated

March 4, 2009

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

August 4, 2008

Last Update Submit

March 3, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • Patients will be evaluated according to the adverse reactions and the intensity of them.

    21 days

Study Arms (1)

1

EXPERIMENTAL

Cetylpyridinium chloride during 21 consecutive days.

Drug: Cetylpyridinium chloride

Interventions

Cetylpyridinium chlorideDRUG

Cetylpyridinium chloride during 21 consecutive days.

1

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Integral buccal mucous (without oral pathologies);
  • Normal odontological exams;

You may not qualify if:

  • Lactation or gestational risk or gestation;
  • Use of Antiinflammatory 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Cetylpyridinium

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jaderson Lima, MD

    Sanofi-aventis administrative office Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

July 1, 2008

Primary Completion

August 1, 2008

Last Updated

March 4, 2009

Record last verified: 2009-03

Locations

BR(1)