To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

This study is currently recruiting participants.

Verified January 2013 by PMG Pharm Co., Ltd

Sponsor:

Information provided by (Responsible Party):

PMG Pharm Co., Ltd

ClinicalTrials.gov Identifier:

NCT01768468

First received: January 11, 2013

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: LAYLA tablet Drug: JOINS tablet	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by PMG Pharm Co., Ltd:

Primary Outcome Measures:

Change in 100mm Pain VAS [ Time Frame: baseline throgh week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in 100mm pain VAS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change rate from baseline in 100mm Pain VAS [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in WOMAC [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in EQ-5D [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Change in the patient self-assessed & investigator-assessed overall symptom score [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Consumption of rescue medication [ Time Frame: 4 times ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	October 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LAYLA Drug : LAYLA tablet/ bid	Drug: LAYLA tablet 1 tablet twice a day Other Name: LAYLA 405.4mg
Active Comparator: JOINS Drug : JOINS tablet/ tid	Drug: JOINS tablet 1 tablet at each time, 3 times a day Other Name: JOINS 200mg

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768468

Contacts

Contact: Ye Soo Park, MD

hyparkys@hanyang.ac.kr

Locations

Korea, Republic of
Keimyug University Dongsan Medical Center	Recruiting
Daegu, Korea, Republic of
Principal Investigator: Byung Woo Min
Hanyang University Guri Hospital	Recruiting
Seoul, Korea, Republic of
Principal Investigator: Ye Soo Park
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of
Principal Investigator: Chul Won Ha
Korea University Anam Hospital	Recruiting
Seoul, Korea, Republic of
Principal Investigator: Seong Beom Han
SMG-SNU Boramae Medical Center	Recruiting
Seoul, Korea, Republic of
Principal Investigator: Jae Hyup Lee
Ajou University Hospital	Recruiting
Suwon, Korea, Republic of
Principal Investigator: Ye Yeon Won

Sponsors and Collaborators

PMG Pharm Co., Ltd

Investigators

Principal Investigator:	Ye Soo Park	Hanyang University
Principal Investigator:	Chul Won Ha	Samsung Medical Center
Principal Investigator:	Ye Yeon Won	Ajou University School of Medicine
Principal Investigator:	Jae Hyup Lee	SMG-SNU Boramae Medical Center
Principal Investigator:	Byung Woo Min	Keimyug University Dongsan Medical Center
Principal Investigator:	Seung Beom Han	Korea University Anam Hospital

More Information

No publications provided

Responsible Party:	PMG Pharm Co., Ltd
ClinicalTrials.gov Identifier:	NCT01768468 History of Changes
Other Study ID Numbers:	LAYLA-P4
Study First Received:	January 11, 2013
Last Updated:	January 14, 2013
Health Authority:	Korea: Institutional Review Board

Keywords provided by PMG Pharm Co., Ltd:

LAYLA
Non-inferiority
100mm pain VAS

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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