NCT02554240

Brief Summary

This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

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

December 23, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2016

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

1.5 years

First QC Date

April 28, 2015

Last Update Submit

April 13, 2021

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3

    week 3

Secondary Outcomes (8)

  • Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12

    week 1,2,7,12

  • Change from baseline of 100mm-VAS about Resting pain in study knee at week 1,2,3,7,12

    week 1,2,3,7,12

  • knee joint range of motion change (Observation by investigator)

    24 weeks

  • knee joint effusion change (Observation by investigator)

    24 weeks

  • overall assessment of subject and investigator (5-Likert scale)

    week 1,2,3,7,12

  • +3 more secondary outcomes

Study Arms (3)

DA-5202 High dose

EXPERIMENTAL

\- DA-5202 20mg

Drug: DA-5202 20mg

DA-5202 Low dose

EXPERIMENTAL

\- DA-5202 10mg

Drug: DA-5202 10mg

Na Hyaluronate 20mg

ACTIVE COMPARATOR

Na Hyaluronate 20mg

Drug: Na Hyaluronate 20mg

Interventions

DA-5202 20mgDRUG

once a week, intra-articular injection, for 3 weeks

Also known as: DA-5202 high dose
DA-5202 High dose
DA-5202 10mgDRUG

once a week, intra-articular injection, for 3 weeks

Also known as: DA-5202 low dose
DA-5202 Low dose
Na Hyaluronate 20mgDRUG

once a week, intra-articular injection, for 3 weeks

Also known as: Hyruan Plus®
Na Hyaluronate 20mg

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male and female patients between 20 and 80 y old
  • primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria and have following 3 items
  • knee joint pain
  • have any of the following
  • males and females more than 50 y
  • morning stiffness within 30 minutes
  • crepitus
  • presence of spur on radiological evidence
  • Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically
  • knee pain under weight-bearing greater than 40/100mm-VAS(Visual Analogue Scale) at randomization visit
  • patients willing and able to provide signed informed consent after the nature of the study has been explained

You may not qualify if:

  • BMI(Body Mass Index) \> 32
  • complete obliteration of femoropatellar joint space on X-ray
  • Kellgren-Lawrence Grade IV
  • knee surgery within a year
  • history of fracture, rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
  • intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
  • skin diseases or infection overlying the joint
  • history of severe drug allergy or hypersensitivity to drugs(piroxicam, hyaluronic acid)
  • history of allergy, asthma, rhinitis, angioedema, rash to aspirin or other NSAIDs (including COX-2 inhibitor)
  • treatment with anticoagulants such as heparin or coumarins (warfarin etc.)
  • History of GI diseases such as peptic ulcer, bleeding, perforation, ulcerative colitis, Crohn's disease within 1 year
  • severe hypertension
  • patients with psychiatric disorder, alcoholism, drug addiction
  • presence of severe concomitant diseases or malignancy within 5 years
  • have participated in another clinical trial 4 weeks prior to the study
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Myung chul Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

September 18, 2015

Study Start

December 23, 2014

Primary Completion

June 29, 2016

Study Completion

October 14, 2016

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations

KR(1)