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To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee

NCT ID: NCT02049606

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-24

Study Completion Date

2016-05-30

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LAYLA

Drug : LAYLA tablet/bid

Group Type EXPERIMENTAL

LAYLA tablet

Intervention Type DRUG

1 Tablet twice a day

CENATONE

Drug : CENATONE tablet/qd

Group Type ACTIVE_COMPARATOR

CENATONE tablet

Intervention Type DRUG

2 Tablets once a day

Interventions

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LAYLA tablet

1 Tablet twice a day

Intervention Type DRUG

CENATONE tablet

2 Tablets once a day

Intervention Type DRUG

Other Intervention Names

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LAYLA 405.4mg Nabumetone 500mg

Eligibility Criteria

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Inclusion Criteria

* Patients ≥40 and ≤80 years of age
* Radiographic evidence of grade 1,2 or 3 osteoarthritis based on the Kellgren \& Lawrence radiographic entry criteria
* Stable osteoarthritis during 3 months
* Score of 100mm Pain VAS ≤ 80mm at screening
* Score of 100mm Pain VAS ≥ 40mm at baseline
* Written consent form voluntarily

Exclusion Criteria

* Disease of spine or other Lower limb joints that could affect fo 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
* Diagnosed with psychical disorder, and taking medication
* Medication of intra-articular injection within 3 months
* Uncontrollable Hypertension patients at screening test
* History of upper gastrointestinal ulceration within 6 months, History of upper gastrointestinal bleeding within 12 months
* History of lower gastrointestinal bleeding within 12 months
* History of coronary artery bypass, systemic lupus erythematosus or mixed connective tissue disease
* Serum creatinine, ALT, AST, total bilirubin over ULN X 2.0 at screening test
* History of hypersensitivity of LAYLA, CENATONE 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
* History of malignant tumor within 5 years
* Investigator's judgment
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PMG Pharm Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seung Baik Kang, MD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Jeong Ku Ha, MD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Han Jun Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Yong In, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Jong Min Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Sahng Hoon Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Inje University Seoul Paik Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LAYLA_P4_NB

Identifier Type: -

Identifier Source: org_study_id