NCT01768468

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

January 11, 2013

Last Update Submit

October 11, 2013

Conditions

Osteoarthritis of the Knee

Keywords

LAYLANon-inferiority100mm pain VAS

Outcome Measures

Primary Outcomes (1)

  • Change in 100mm Pain VAS

    baseline throgh week 8

Secondary Outcomes (6)

  • Change from baseline in 100mm pain VAS

    12 weeks

  • Change rate from baseline in 100mm Pain VAS

    8 weeks, 12 weeks

  • Change from baseline in WOMAC

    8 weeks, 12 weeks

  • Change from baseline in EQ-5D

    8 weeks, 12 weeks

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

    8 weeks, 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

LAYLA

EXPERIMENTAL

Drug : LAYLA tablet/ bid

Drug: LAYLA tablet

JOINS

ACTIVE COMPARATOR

Drug : JOINS tablet/ tid

Drug: JOINS tablet

Interventions

LAYLA tabletDRUG

1 tablet twice a day

Also known as: LAYLA 405.4mg
LAYLA
JOINS tabletDRUG

1 tablet at each time, 3 times a day

Also known as: JOINS 200mg
JOINS

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Keimyug University Dongsan Medical Center

Daegu, South Korea

Location

Hanyang University Guri Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (1)

  • Ha CW, Park YB, Min BW, Han SB, Lee JH, Won YY, Park YS. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25.

    PMID: 26821189DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ye Soo Park

    Hanyang University Guri Hospital

    PRINCIPAL INVESTIGATOR

  • Chul Won Ha

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Ye Yeon Won

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Jae Hyup Lee

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

  • Byung Woo Min

    Keimyug University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

  • Seung Beom Han

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 15, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations

KR(6)