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Completed

NCT Number: NCT01768468

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Keimyug University Dongsan Medical Center, Daegu, 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 ≤ 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

Treatment and study plan

LAYLA tablet

Drug

1 tablet twice a day

Other names: LAYLA 405.4mg

JOINS tablet

Drug

1 tablet at each time, 3 times a day

Other names: JOINS 200mg

Primary outcomes

  1. Change in 100mm Pain VAS

    Time frame: baseline throgh week 8

Secondary outcomes

  1. Change from baseline in 100mm pain VAS

    Time frame: 12 weeks

  2. Change rate from baseline in 100mm Pain VAS

    Time frame: 8 weeks, 12 weeks

  3. Change from baseline in WOMAC

    Time frame: 8 weeks, 12 weeks

  4. Change from baseline in EQ-5D

    Time frame: 8 weeks, 12 weeks

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

    Time frame: 8 weeks, 12 weeks

  6. Consumption of rescue medication

    Time frame: 4 times

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 15, 2013
Registry last updated
Oct 14, 2013

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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