Chronic PeriodontitisPhase 2YH14642NCT01499225
A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease
A Phase 2 study testing YH14642 500mg Tab, INSADOL[Zea mays L. extract] 35mg Tab and DENTISTA[Doxycycline hyclate] 20mg Cap 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 YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- YH14642 500mg Tab, INSADOL[Zea mays L. extract] 35mg Tab and DENTISTA[Doxycycline hyclate] 20mg Cap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Jul 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 20 years of age or older
- Have at least 18 natural teeth
- Four or more clinical attachment level(CAL) ≥ 3mm
- Four or more periodontal pockets with a probing depth (PD) ≥ 4mm
- Have Bleeding on probing
- Provide informed consent and willingness to cooperate with the study protocol
Who cannot join
- Forbidden History of Panax Notoginseng and Rehmanniae Radix Preparata
- Hypersensitivity of Doxycycline
- Hypersensitivity of Zea mays L. extract
- Critical diseases such as HIV previous three years
- Patients with mental retardation and dementia
- Systemic diseases such as diabetes and hypertension
Show all 13Show fewer
- Patients who take Anticoagulants or Antiplatelet Agents
- Patients who have malignant tumor
- Smoker
- Continually use for 2weeks of phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
- Patients who need malignant tumor
- Patients who received periodontal treatment within the last 6 months
- Pregnant or lactating females
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 YH14642 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease
This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.
- Conditions
- Chronic Periodontitis
- Being tested
- YH14642 500mg Tab, INSADOL[Zea mays L. extract] 35mg Tab, DENTISTA[Doxycycline hyclate] 20mg Cap, 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.
YH14642 500mg TabDrug
YH14642 500mg per day(once a day)
YH14642 500mg TabDrug
YH14642 1000mg per day(twice a day)
YH14642 500mg TabDrug
YH14642 2000mg per day(three times a day)
INSADOL[Zea mays L. extract] 35mg TabDrug
[Initiation dose : 4weeks after administraion] INSADOL[Zea mays L. extract] 210mg TAB per day
[Maintain dose : Between 4weeks and 8weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day
[Maintain dose : Between 8weeks and 12weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day
DENTISTA[Doxycycline hyclate] 20mg CapDrug
DENTISTA[Doxycycline hyclate] Cap 40mg per day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| YH14642 A-I | Experimental | Not described Receives: Drug: YH14642 500mg Tab |
| YH14642 A-II | Experimental | Not described Receives: Drug: YH14642 500mg Tab |
| YH14642 A-III | Experimental | Not described Receives: Drug: YH14642 500mg Tab |
| Active Comparator B | Active comparator | Not described Receives: Drug: INSADOL[Zea mays L. extract] 35mg Tab |
| Active Comparator C | Active comparator | Not described Receives: Drug: DENTISTA[Doxycycline hyclate] 20mg Cap |
| Placebo | Placebo comparator | Not described 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, 8weeks and 12weeks
Secondary outcomes (7)
Change in Clinical attachment level (CAL)
Measured: baseline, 4weeks, 8weeks and 12weeks
Change in Bleeding on probing(BOP)
Measured: baseline, 4weeks, 8weeks and 12weeks
change in Gingival index(GI)
Measured: baseline, 4weeks, 8weeks and 12weeks
Change in Plaque index (PI)
Measured: baseline, 4weeks, 8weeks and 12weeks
Change in Gingival recession(GR)
Measured: baseline, 4weeks, 8weeks and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)
Measured: baseline and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)
Measured: baseline and 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499225
- Sponsor's protocol ID
- YH14642-201
- Acronym
- YH14642
- Status last verified
- Jul 2014
- First submitted
- 13 Dec 2011
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
PubMed 33197289
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. 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 YH14642 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease
- ClinicalTrials.gov ID
- NCT01499225
- Acronym / sponsor ID
- YH14642 / YH14642-201
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- First posted
- 26 Dec 2011 (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 YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| YH14642 A-I | Experimental | Drug: YH14642 500mg Tab |
| YH14642 A-II | Experimental | Drug: YH14642 500mg Tab |
| YH14642 A-III | Experimental | Drug: YH14642 500mg Tab |
| Active Comparator B | Active comparator | Drug: INSADOL[Zea mays L. extract] 35mg Tab |
| Active Comparator C | Active comparator | Drug: DENTISTA[Doxycycline hyclate] 20mg Cap |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be 20 years of age or older
- Have at least 18 natural teeth
- Four or more clinical attachment level(CAL) ≥ 3mm
- Four or more periodontal pockets with a probing depth (PD) ≥ 4mm
- Have Bleeding on probing
Key exclusion criteria (13 listed)
- Forbidden History of Panax Notoginseng and Rehmanniae Radix Preparata
- Hypersensitivity of Doxycycline
- Hypersensitivity of Zea mays L. extract
- Critical diseases such as HIV previous three years
- Patients with mental retardation and dementia
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 |
|---|---|---|
| YH14642 500mg TabYH14642 500mg per day(once a day) | Drug | YH14642 A-I |
| YH14642 500mg TabYH14642 1000mg per day(twice a day) | Drug | YH14642 A-II |
| YH14642 500mg TabYH14642 2000mg per day(three times a day) | Drug | YH14642 A-III |
| INSADOL[Zea mays L. extract] 35mg Tab[Initiation dose : 4weeks after administraion] INSADOL[Zea mays L. extract] 210mg TAB per day [Maintain dose : Between 4weeks and 8weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day [Maintain dose : Between 8weeks and 12weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day | Drug | Active Comparator B |
| DENTISTA[Doxycycline hyclate] 20mg CapDENTISTA[Doxycycline hyclate] Cap 40mg per day | Drug | Active Comparator C |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in probing pocket depth (PD)
Time frame: baseline, 4weeks, 8weeks and 12weeks
7 secondary outcomes
Change in Clinical attachment level (CAL)
Time frame: baseline, 4weeks, 8weeks and 12weeks
Change in Bleeding on probing(BOP)
Time frame: baseline, 4weeks, 8weeks and 12weeks
change in Gingival index(GI)
Time frame: baseline, 4weeks, 8weeks and 12weeks
Change in Plaque index (PI)
Time frame: baseline, 4weeks, 8weeks and 12weeks
Change in Gingival recession(GR)
Time frame: baseline, 4weeks, 8weeks and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)
Time frame: baseline and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)
Time frame: baseline and 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 31 Jul 2014.
- Derived from this study: PubMed 33197289Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 YH14642 500mg Tab, INSADOL[Zea mays L. extract] 35mg Tab and DENTISTA[Doxycycline hyclate] 20mg Cap 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 6 inclusion and 13 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 31 Jul 2014. 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, 8weeks and 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01499225, which also lists 1 linked publication.
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 31 Jul 2014.