NCT02594449

Brief Summary

To compare pharmacodynamics among the different concentrations of BCS and NS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy-volunteers

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

October 29, 2015

Last Update Submit

November 2, 2015

Conditions

Healthy Volunteers

Keywords

Pharmacodynamic Study of BCS

Outcome Measures

Primary Outcomes (1)

  • The changes of aerobic bacterial colonization in oropharyngeal

    To collect the throat swab samples and supragingival plaque samples before and post administration, respectively, a total of 11 time points.

    24 hours

Secondary Outcomes (2)

  • The improvement of oral healthy status

    24 hours

  • The volunteers' feelings

    24 hours

Study Arms (3)

low concentration Benzalkonium Chloride

ACTIVE COMPARATOR

To use low concentration Benzalkonium Chloride Solution to gargle

Drug: Benzalkonium Chloride Solution

high concentration Benzalkonium Chloride

ACTIVE COMPARATOR

To use high concentration Benzalkonium Chloride Solution to gargle

Drug: Benzalkonium Chloride Solution

Normal Saline

PLACEBO COMPARATOR

To use Normal Saline to gargle

Drug: Benzalkonium Chloride Solution

Interventions

Benzalkonium Chloride SolutionDRUG

To compare pharmacodynamics among the different concentrations of BCS and NS

Also known as: Youkeshi
Normal Salinehigh concentration Benzalkonium Chloridelow concentration Benzalkonium Chloride

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, males or females.
  • Females with U-HCG negative.
  • Signed ICFs, and could conduct this study with investigators.

You may not qualify if:

  • History of mouthwash allergies, allergic rhinitis or dermatitis.
  • Volunteers with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer.
  • Volunteers with removable denture.
  • Had received special oral clean.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Study Officials

  • Shiyue Li, Professor

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

November 3, 2015

Record last verified: 2015-10

Locations

CN(1)