Chronic PeriodontitisPhase 2NCT02585596
A Phase II Clinical Trial of YH23537 in Patients With Chronic Periodontal Disease.
A Phase 2 study testing YH23537 1000mg/day, YH23537 2000mg/day and YH23537 3000mg/day in people with Chronic Periodontitis, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- YH23537 1000mg/day, YH23537 2000mg/day and YH23537 3000mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2015to 27 Jun 2017
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 19 years of age or older
- Have at least 18 natural teeth
- have been diagnosed with chronic periodontitis
- have been diagnosed Mild/Moderate/Severe periodontitis with according to CDC / AAP periodontal classification (2012))
- Provide informed consent and willingness to cooperate with the study protocol
Who cannot join
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product.
- Pregnant or lactating females
- Systemic diseases such as diabetes and hypertension
- Patients who take Anticoagulants or Antiplatelet Agents
- Continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
- Patients who received periodontal treatment within the last 6 months
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- Patients who have malignant tumor
- History of positive serologic evidence of current infectious liver disease including HbsAg, or anti-HCV.
- Patients with mental retardation and dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH23537 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease
This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.
Read the detailed description
at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).
- Conditions
- Chronic Periodontitis
- Being tested
- YH23537 1000mg/day, YH23537 2000mg/day, YH23537 3000mg/day, placebo
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH23537 1000mg/dayDrug
YH23537 500mg 2 tab
YH23537 2000mg/dayDrug
YH23537 500mg 4 tab
YH23537 3000mg/dayDrug
YH23537 500mg 6 tab
placeboDrug
YH23537 500mg tab placebo
| Study group | Role | What they receive |
|---|---|---|
| YH23537 1000mg/day | Experimental | YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks Receives: Drug: YH23537 1000mg/day; Drug: placebo |
| YH23537 2000mg/day | Experimental | YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks Receives: Drug: YH23537 2000mg/day; Drug: placebo |
| YH23537 3000mg/day | Experimental | YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks Receives: Drug: YH23537 3000mg/day |
| YH23537 3000mg/day loading 1000mg/day | Experimental | YH23537 500mg 3tab twice a day (before morning,evening meal) during 4weeks and YH23537 500mg tab twice a day (before morning,evening meal) during 8weeks Receives: Drug: YH23537 1000mg/day; Drug: YH23537 3000mg/day; Drug: placebo |
| Placebo | Placebo comparator | YH23537 500mg placebo 3tab twice a day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing pocket depth (PD)
Measured: baseline, 4weeks, 8week, 12weeks
Secondary outcomes (3)
Change in Clinical attachment level (CAL)
Measured: baseline, 4weeks, 8week, 12weeks
Change in Bleeding on probing(BOP)
Measured: baseline, 4weeks, 8week, 12weeks
Change in Gingival recession(GR)
Measured: baseline, 4weeks, 8week, 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start16 Dec 2015
- Primary completion28 Dec 2016
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incheol Rhyu, Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585596
- Sponsor's protocol ID
- YH23537-201
- Status last verified
- Jan 2019
- First submitted
- 21 Oct 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH23537 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease
- ClinicalTrials.gov ID
- NCT02585596
- Acronym / sponsor ID
- YH23537-201
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 23 Oct 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.
This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.
Detailed description
at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| YH23537 1000mg/day | Experimental | Drug: YH23537 1000mg/day, Drug: placeboYH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks |
| YH23537 2000mg/day | Experimental | Drug: YH23537 2000mg/day, Drug: placeboYH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks |
| YH23537 3000mg/day | Experimental | Drug: YH23537 3000mg/dayYH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks |
| YH23537 3000mg/day loading 1000mg/day | Experimental | Drug: YH23537 1000mg/day, Drug: YH23537 3000mg/day, Drug: placeboYH23537 500mg 3tab twice a day (before morning,evening meal) during 4weeks and YH23537 500mg tab twice a day (before morning,evening meal) during 8weeks |
| Placebo | Placebo comparator | Drug: placeboYH23537 500mg placebo 3tab twice a day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be 19 years of age or older
- Have at least 18 natural teeth
- have been diagnosed with chronic periodontitis
- have been diagnosed Mild/Moderate/Severe periodontitis with according to CDC / AAP periodontal classification (2012))
- Provide informed consent and willingness to cooperate with the study protocol
Key exclusion criteria (9 listed)
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 4 weeks after the last dose of investigational product.
- Pregnant or lactating females
- Systemic diseases such as diabetes and hypertension
- Patients who take Anticoagulants or Antiplatelet Agents
- Continually use for phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
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 |
|---|---|---|
| YH23537 1000mg/dayYH23537 500mg 2 tab | Drug | YH23537 1000mg/day, YH23537 3000mg/day loading 1000mg/day |
| YH23537 2000mg/dayYH23537 500mg 4 tab | Drug | YH23537 2000mg/day |
| YH23537 3000mg/dayYH23537 500mg 6 tab | Drug | YH23537 3000mg/day, YH23537 3000mg/day loading 1000mg/day |
| placeboYH23537 500mg tab placebo | Drug | Placebo, YH23537 1000mg/day, YH23537 2000mg/day, YH23537 3000mg/day loading 1000mg/day |
Primary outcome
Change in probing pocket depth (PD)
Time frame: baseline, 4weeks, 8week, 12weeks
3 secondary outcomes
Change in Clinical attachment level (CAL)
Time frame: baseline, 4weeks, 8week, 12weeks
Change in Bleeding on probing(BOP)
Time frame: baseline, 4weeks, 8week, 12weeks
Change in Gingival recession(GR)
Time frame: baseline, 4weeks, 8week, 12weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Incheol Rhyu, Ph.D. study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YH23537 1000mg/day, YH23537 2000mg/day and YH23537 3000mg/day in people with Chronic Periodontitis, run by Yuhan Corporation at 1 site in South Korea.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 16 Jan 2019. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in probing pocket depth (PD) (time frame: baseline, 4weeks, 8week, 12weeks). 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 16 Jan 2019.