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

Osteoarthritis of the Knee Clinical Trial

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 of the Knee.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049606
• Other study ID #: LAYLA_P4_NB
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2014
• Last updated: September 18, 2017
• Start date: February 24, 2014
• Est. completion date: May 30, 2016

Study information

• Verified date: September 2017
• Source: PMG Pharm Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 30, 2016
• Est. primary completion date: May 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• LAYLA tablet
1 Tablet twice a day
• CENATONE tablet
2 Tablets once a day

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
PMG Pharm Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from the baseline in 100mm Pain VAS		Baseline through week8
Secondary	Changes rate from the baseline in 100mm Pain VAS		8 weeks
Secondary	Changes from the baseline in WOMAC		8 Weeks
Secondary	Changes from the baseline in EQ-5D		8 Weeks
Secondary	Changes in the patient self-assessed overall symptom score		8 Weeks