Healthy VolunteersPhase 4NCT02594449
A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers
A Phase 4 study testing Benzalkonium Chloride Solution in people with Healthy Volunteers, run by Lustre Pharmaceutical Lab Co., Ltd at 1 site in China.
Trial summary
To compare pharmacodynamics among the different concentrations of BCS and NS. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Benzalkonium Chloride Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, males or females.
- Females with U-HCG negative.
- Signed ICFs, and could conduct this study with investigators.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
About this study
Official title: A Pharmacodynamic and Safety Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Healthy Volunteers
To compare pharmacodynamics among the different concentrations of BCS and NS.
Read the detailed description
2 times mouthwash in the morning and at night. To collect bacterium samples to assess the pharmacodynamics among the different concentrations of BCS and NS: observe the changes of aerobic bacterial colonization in oropharyngeal over time during 24 hours, and assess the improvement of oral healthy status and the subjective feelings after 24 hours.
- Conditions
- Healthy Volunteers
- Being tested
- Benzalkonium Chloride Solution
- Keywords
- Pharmacodynamic Study of BCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzalkonium Chloride SolutionDrug
Also called Youkeshi
To compare pharmacodynamics among the different concentrations of BCS and NS
| Study group | Role | What they receive |
|---|---|---|
| low concentration Benzalkonium Chloride | Active comparator | To use low concentration Benzalkonium Chloride Solution to gargle Receives: Drug: Benzalkonium Chloride Solution |
| high concentration Benzalkonium Chloride | Active comparator | To use high concentration Benzalkonium Chloride Solution to gargle Receives: Drug: Benzalkonium Chloride Solution |
| Normal Saline | Placebo comparator | To use Normal Saline to gargle Receives: Drug: Benzalkonium Chloride Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
The improvement of oral healthy status
To use Plaque Index (PLI) to reflect volunteers' oral healthy status.
Measured: 24 hours
The volunteers' feelings
The feelings including: comfortable, general comfortable, uncomfortable.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lustre Pharmaceutical Lab Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiyue Li, Professor, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594449
- Sponsor's protocol ID
- LC-PHB1505
- Status last verified
- Oct 2015
- First submitted
- 29 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic and Safety Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02594449
- Acronym / sponsor ID
- LC-PHB1505
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacodynamic Study of BCS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lustre Pharmaceutical Lab Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare pharmacodynamics among the different concentrations of BCS and NS.
Detailed description
2 times mouthwash in the morning and at night. To collect bacterium samples to assess the pharmacodynamics among the different concentrations of BCS and NS: observe the changes of aerobic bacterial colonization in oropharyngeal over time during 24 hours, and assess the improvement of oral healthy status and the subjective feelings after 24 hours.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low concentration Benzalkonium Chloride | Active comparator | Drug: Benzalkonium Chloride SolutionTo use low concentration Benzalkonium Chloride Solution to gargle |
| high concentration Benzalkonium Chloride | Active comparator | Drug: Benzalkonium Chloride SolutionTo use high concentration Benzalkonium Chloride Solution to gargle |
| Normal Saline | Placebo comparator | Drug: Benzalkonium Chloride SolutionTo use Normal Saline to gargle |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers, males or females.
- Females with U-HCG negative.
- Signed ICFs, and could conduct this study with investigators.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzalkonium Chloride SolutionAlso: YoukeshiTo compare pharmacodynamics among the different concentrations of BCS and NS | Drug | Normal Saline, high concentration Benzalkonium Chloride, low concentration Benzalkonium Chloride |
Primary outcome
The changes of aerobic bacterial colonization in oropharyngeal
Time frame: 24 hours
To collect the throat swab samples and supragingival plaque samples before and post administration, respectively, a total of 11 time points.
2 secondary outcomes
The improvement of oral healthy status
Time frame: 24 hours
The volunteers' feelings
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyue Li, Professor principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzalkonium Chloride Solution in people with Healthy Volunteers, run by Lustre Pharmaceutical Lab Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of aerobic bacterial colonization in oropharyngeal (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.