To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768468
• Other study ID #: LAYLA-P4
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2013
• Last updated: October 11, 2013
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: PMG Pharm Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• LAYLA tablet
1 tablet twice a day
• JOINS tablet
1 tablet at each time, 3 times a day

Locations

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

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	Change in 100mm Pain VAS		baseline throgh week 8	No
Secondary	Change from baseline in 100mm pain VAS		12 weeks	No
Secondary	Change rate from baseline in 100mm Pain VAS		8 weeks, 12 weeks	No
Secondary	Change from baseline in WOMAC		8 weeks, 12 weeks	No
Secondary	Change from baseline in EQ-5D		8 weeks, 12 weeks	No
Secondary	Change in the patient self-assessed & investigator-assessed overall symptom score		8 weeks, 12 weeks	No
Secondary	Consumption of rescue medication		4 times	No