A Study to Evaluate the Efficacy and Safety of ALH-L1005... | NCT04503746

Studies
A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis

NCT04503746

Sponsor

AngioLab, Inc.

Status

Completed

Last Update Posted

Aug 11, 2022Actual

Enrollment

117Actual

Phase

Phase 2

Conditions

Chronic Periodontitis

Interventions

ALH-L1005 600mg/day
ALH-L1005 1,200mg/day
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2020Actual

Primary Completion Date

Dec 13, 2021Actual

Completion Date

Dec 13, 2021Actual

First Submitted Date

Aug 5, 2020

First Submission Date that Met QC Criteria

Aug 5, 2020

First Posted Date

Aug 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2022

Last Update Posted Date

Aug 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo twice a day	Drug: Placebo
ALH-L1005 600 mg	Experimental	ALH-L1005 300 mg twice a day	Drug: ALH-L1005 600mg/day
ALH-L1005 1,200 mg	Experimental	ALH-L1005 600 mg twice a day	Drug: ALH-L1005 1,200mg/day

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALH-L1005 600mg/day	Drug	ALH-L1005 300mg 2 tablet and placebo 2 tablet	ALH-L1005 600 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Pocket Depth(PD)	Change in Pocket Depth in Subjects	baseline, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Pocket Depth(PD)	Change in Pocket Depth in Subjects	baseline, 4 weeks, 8 weeks
Change in Clinical Attachment Level(CAL)	Change in Clinical Attachment Level in Subjects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AngioLab, Inc.		Daejeon	Daejeon Gwangyeogsi	34015	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055113	Chronic Periodontitis
D010518	Periodontitis

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided