NCT02049606

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Typical duration 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

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

February 24, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

January 28, 2014

Last Update Submit

September 18, 2017

Conditions

Osteoarthritis of the Knee

Keywords

LAYLANon-inferiority100mm pain VAS

Outcome Measures

Primary Outcomes (1)

  • Changes from the baseline in 100mm Pain VAS

    Baseline through week8

Secondary Outcomes (4)

  • Changes rate from the baseline in 100mm Pain VAS

    8 weeks

  • Changes from the baseline in WOMAC

    8 Weeks

  • Changes from the baseline in EQ-5D

    8 Weeks

  • Changes in the patient self-assessed overall symptom score

    8 Weeks

Study Arms (2)

LAYLA

EXPERIMENTAL

Drug : LAYLA tablet/bid

Drug: LAYLA tablet

CENATONE

ACTIVE COMPARATOR

Drug : CENATONE tablet/qd

Drug: CENATONE tablet

Interventions

LAYLA tabletDRUG

1 Tablet twice a day

Also known as: LAYLA 405.4mg
LAYLA
CENATONE tabletDRUG

2 Tablets once a day

Also known as: Nabumetone 500mg
CENATONE

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Nabumetone

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ButanonesKetonesOrganic Chemicals

Study Officials

  • Seung Baik Kang, MD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

  • Jeong Ku Ha, MD

    Inje University

    PRINCIPAL INVESTIGATOR

  • Han Jun Lee, MD

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

  • Yong In, MD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Jong Min Kim, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Sahng Hoon Lee, MD

    Seoul National University 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 28, 2014

First Posted

January 30, 2014

Study Start

February 24, 2014

Primary Completion

May 11, 2015

Study Completion

May 30, 2016

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

KR(6)