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To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

LAYLA tablet

JOINS tablet

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring LAYLA, Non-inferiority, 100mm pain VAS

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients ≥40 and ≤ 80years of age
Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren & Lawrene radiographic entry criteria
Stable osteoarthritis during 3 months
Score of 100mm pain VAS ≤ 80mm at screening
Score of 100mm pain VAS ≥ 50mm at baseline
Written consent form voluntarily

Exclusion Criteria:

Disease of spine or other Lower limb joints that could affect to evaluate the efficacy
History of surgery or arthroscopy of the study joint within 6 months
Trauma of study joint within 12 months
Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
Medication of intra-articular injection within 3 months
Diagnosed with psychical disorder, and taking medication
History of upper gastrointestinal ulceration within 6 months
History of upper gastrointestinal bleeding within 12 months
Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test
History of hypersensitivity to LAYLA, JOINS, or NSAIDs
Participation in another clinical trials within 4 weeks
Medication of constantly (more than 1 week) narcotic analgesics within 3 months
Not consent about using effectual contraception method during trial
Pregnant or lactating woman
Investigator's judgment

Sites / Locations

Keimyug University Dongsan Medical Center
Hanyang University Guri Hospital
Korea University Anam Hospital
Samsung Medical Center
SMG-SNU Boramae Medical Center
Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LAYLA

JOINS

Arm Description

Drug : LAYLA tablet/ bid

Drug : JOINS tablet/ tid

Outcomes

Primary Outcome Measures

Change in 100mm Pain VAS

Secondary Outcome Measures

Change from baseline in 100mm pain VAS

Change rate from baseline in 100mm Pain VAS

Change from baseline in WOMAC

Change from baseline in EQ-5D

Change in the patient self-assessed & investigator-assessed overall symptom score

Consumption of rescue medication

Full Information

NCT ID

NCT01768468

First Posted

January 11, 2013

Last Updated

October 11, 2013

Sponsor

PMG Pharm Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01768468

Brief Title

To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

Official Title

Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PMG Pharm Co., Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

LAYLA, Non-inferiority, 100mm pain VAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LAYLA

Arm Type

Experimental

Arm Description

Drug : LAYLA tablet/ bid

Arm Title

JOINS

Arm Type

Active Comparator

Arm Description

Drug : JOINS tablet/ tid

Intervention Type

Drug

Intervention Name(s)

LAYLA tablet

Other Intervention Name(s)

LAYLA 405.4mg

Intervention Description

1 tablet twice a day

Intervention Type

Drug

Intervention Name(s)

JOINS tablet

Other Intervention Name(s)

JOINS 200mg

Intervention Description

1 tablet at each time, 3 times a day

Primary Outcome Measure Information:

Title

Change in 100mm Pain VAS

Time Frame

baseline throgh week 8

Secondary Outcome Measure Information:

Title

Change from baseline in 100mm pain VAS

Time Frame

12 weeks

Title

Change rate from baseline in 100mm Pain VAS

Time Frame

8 weeks, 12 weeks

Title

Change from baseline in WOMAC

Time Frame

8 weeks, 12 weeks

Title

Change from baseline in EQ-5D

Time Frame

8 weeks, 12 weeks

Title

Change in the patient self-assessed & investigator-assessed overall symptom score

Time Frame

8 weeks, 12 weeks

Title

Consumption of rescue medication

Time Frame

4 times

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients ≥40 and ≤ 80years of age Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren & Lawrene radiographic entry criteria Stable osteoarthritis during 3 months Score of 100mm pain VAS ≤ 80mm at screening Score of 100mm pain VAS ≥ 50mm at baseline Written consent form voluntarily Exclusion Criteria: Disease of spine or other Lower limb joints that could affect to evaluate the efficacy History of surgery or arthroscopy of the study joint within 6 months Trauma of study joint within 12 months Medication of constantly(more than 1 week) corticosteroid by oral within 3 months Medication of intra-articular injection within 3 months Diagnosed with psychical disorder, and taking medication History of upper gastrointestinal ulceration within 6 months History of upper gastrointestinal bleeding within 12 months Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test History of hypersensitivity to LAYLA, JOINS, or NSAIDs Participation in another clinical trials within 4 weeks Medication of constantly (more than 1 week) narcotic analgesics within 3 months Not consent about using effectual contraception method during trial Pregnant or lactating woman Investigator's judgment

Overall Study Officials: