A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis
A Multi-center, Randomized, Double-Blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of 12-week Treatment of ALH-L1005 600 mg or 1200 mg in Patients With Chronic Periodontitis
1 other identifier
interventional
117
1 country
1
Brief Summary
The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2020
CompletedFirst Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedAugust 11, 2022
August 1, 2022
1.4 years
August 5, 2020
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pocket Depth(PD)
Change in Pocket Depth in Subjects
baseline, 12 weeks
Secondary Outcomes (4)
Change in Pocket Depth(PD)
baseline, 4 weeks, 8 weeks
Change in Clinical Attachment Level(CAL)
baseline, 4 weeks, 8 weeks, 12 weeks
Change in Gingival recession(GR)
baseline, 12 weeks
Change in Bleeding on probing(BOP) score
baseline, 12 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo twice a day
ALH-L1005 600 mg
EXPERIMENTALALH-L1005 300 mg twice a day
ALH-L1005 1,200 mg
EXPERIMENTALALH-L1005 600 mg twice a day
Interventions
Eligibility Criteria
You may qualify if:
- Men or women ages 18 and over, under 79 years of age
- Patients diagnosed with chronic periodontitis
- Patients with 4 teeth and over whose pocket depth is ≥ 4 mm and clinical attachment level is ≥ 3 mm
- Patients who are voluntarily participated in clinical trial
You may not qualify if:
- History of antibiotic therapy within the 1 month prior to study
- Those who had undergone any dental surgical or non-surgical therapy within 3 months prior to the start of the study
- Subjects who are pregnant/ lactating
- Smokers
- Patients who take Anticoagulants or Antiplatelet Agents
- With Systemic diseases that affect periodontal conditions such as: diabetes, hypertension and diseases of immune system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AngioLab, Inc.lead
Study Sites (1)
AngioLab, Inc.
Daejeon, Daejeon Gwangyeogsi, 34015, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 7, 2020
Study Start
July 16, 2020
Primary Completion
December 13, 2021
Study Completion
December 13, 2021
Last Updated
August 11, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share