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OpenTrials
Completed

NCT Number: NCT02049606

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAYLA tablet

Drug

1 Tablet twice a day

Other names: LAYLA 405.4mg

CENATONE tablet

Drug

2 Tablets once a day

Other names: Nabumetone 500mg

Primary outcomes

  1. Changes from the baseline in 100mm Pain VAS

    Time frame: Baseline through week8

Secondary outcomes

  1. Changes rate from the baseline in 100mm Pain VAS

    Time frame: 8 weeks

  2. Changes from the baseline in WOMAC

    Time frame: 8 Weeks

  3. Changes from the baseline in EQ-5D

    Time frame: 8 Weeks

  4. Changes in the patient self-assessed overall symptom score

    Time frame: 8 Weeks

Sponsors and collaborators

Lead sponsor

PMG Pharm Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 30, 2014
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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