Recent Updates
Recently added Catalysts

Cetylpyridinium chloride

Phase 3

Undisclosed | Small molecule | Other |Sanofi|Trials Updated: Mar 4, 2009

Cetylpyridinium chloride development status

Highest phase Phase 3
Registered trials 2 across 1 sponsor since May 2008

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment61

FDA Designations

No designations recorded

Cetylpyridinium chloride clinical trials

Cetylpyridinium chloride · 2 trials · 2 indications

Phase 3 2
NCT00729599Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.Hygiene
COMPLETED31 Analytics
NCT00687037Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela PowerHealthy
COMPLETED30 Analytics
PHASE3COMPLETED
Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.
HygieneUnlock trial analytics
PHASE3COMPLETED
Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela Power
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Patients will be evaluated according to the adverse reactions and the intensity of them.
21 days
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
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCetylpyridinium chloride during 21 consecutive days.
IEXPERIMENTALCetylpyridinium chloride during 21 days.

Interventions

NameTypeDescription
Cetylpyridinium chlorideDRUGCetylpyridinium chloride during 21 consecutive days.
Unlock Study Design Details

Eligibility Criteria

Age Range10 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Integral buccal mucous (without oral pathologies); * Normal odontological exams; Exclusion Criteria: * Lactation or gestational risk or gestation; * Use of Antiinflammatory or immunosuppression drugs 15 days before the study; * Being in odontological treatment; * Pathologica...

Countries:Brazil
Unlock Eligibility Criteria

Frequently asked questions about Cetylpyridinium chloride

What is cetylpyridinium chloride?

Cetylpyridinium chloride is a small molecule developed by Sanofi (ticker SNY). It has been studied in Phase 3 clinical trials in Brazil, where it was evaluated for safety, dermatological acceptability, and oral hygiene outcomes in healthy volunteers. The specific therapeutic indication for the drug has not been publicly disclosed.

Who makes cetylpyridinium chloride?

Cetylpyridinium chloride is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 studies of the drug conducted in Brazil. The trials examined safety and acceptability with odontological follow up in healthy volunteer populations.

What phase is cetylpyridinium chloride in?

Cetylpyridinium chloride has been studied in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The studies were conducted in Brazil and enrolled a combined total of 61 participants.

What clinical trials is cetylpyridinium chloride in?

Cetylpyridinium chloride has been evaluated in two completed Phase 3 trials. NCT00729599 studied safety dermatological evaluation and acceptability with odontological follow up in 31 participants aged 10 years and older. NCT00687037 evaluated safety of the oral mucosa and acceptability with odontological follow up in 30 healthy participants aged 18 and older. Both trials took place in Brazil.

How many patients were enrolled in cetylpyridinium chloride trials?

The two completed Phase 3 trials of cetylpyridinium chloride enrolled a combined total of 61 participants. NCT00729599 enrolled 31 participants, and NCT00687037 enrolled 30 participants. Both studies were uncontrolled, non-randomized, and conducted in Brazil with healthy volunteers.