To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

October 11, 2013 updated by: PMG Pharm Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Keimyug University Dongsan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of
        • Hanyang University Guri Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LAYLA
Drug : LAYLA tablet/ bid
Drug: LAYLA tablet
1 tablet twice a day
Other Names:
  • LAYLA 405.4mg
ACTIVE_COMPARATOR: JOINS
Drug : JOINS tablet/ tid
Drug: JOINS tablet
1 tablet at each time, 3 times a day
Other Names:
  • JOINS 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 100mm Pain VAS
Time Frame: baseline throgh week 8
baseline throgh week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in 100mm pain VAS
Time Frame: 12 weeks
12 weeks
Change rate from baseline in 100mm Pain VAS
Time Frame: 8 weeks, 12 weeks
8 weeks, 12 weeks
Change from baseline in WOMAC
Time Frame: 8 weeks, 12 weeks
8 weeks, 12 weeks
Change from baseline in EQ-5D
Time Frame: 8 weeks, 12 weeks
8 weeks, 12 weeks
Change in the patient self-assessed & investigator-assessed overall symptom score
Time Frame: 8 weeks, 12 weeks
8 weeks, 12 weeks
Consumption of rescue medication
Time Frame: 4 times
4 times

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (ESTIMATE)

January 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAYLA-P4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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