Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

April 13, 2021 updated by: Dong-A ST Co., Ltd.

Active-controlled, Dose-Response, Randomized, Double-blind, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

    1. knee joint pain

    2. have any of the following

      1. males and females more than 50 y
      2. morning stiffness within 30 minutes
      3. crepitus
    3. 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

Exclusion Criteria:

  • 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
  • women of child-bearing potential who are not using *adequate means of contraception (*adequate means of contraception: condom, oral contraception, barrier methods using spermicide, intrauterine devices etc.)
  • any condition that, in the view of the investigator, would interfere with study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: DA-5202 High dose
- DA-5202 20mg
Drug: DA-5202 20mg
once a week, intra-articular injection, for 3 weeks
Other Names:
  • DA-5202 high dose
EXPERIMENTAL: DA-5202 Low dose
- DA-5202 10mg
Drug: DA-5202 10mg
once a week, intra-articular injection, for 3 weeks
Other Names:
  • DA-5202 low dose
ACTIVE_COMPARATOR: Na Hyaluronate 20mg
Drug: Na Hyaluronate 20mg
once a week, intra-articular injection, for 3 weeks
Other Names:
  • Hyruan Plus®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline of 100mm-VAS about weight bearing pain in study knee at week 3
Time Frame: week 3
week 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline of 100mm-VAS about Weight bearing pain in study knee at week 1,2,7,12
Time Frame: 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
Time Frame: week 1,2,3,7,12
week 1,2,3,7,12
knee joint range of motion change (Observation by investigator)
Time Frame: 24 weeks
24 weeks
knee joint effusion change (Observation by investigator)
Time Frame: 24 weeks
24 weeks
overall assessment of subject and investigator (5-Likert scale)
Time Frame: week 1,2,3,7,12
week 1,2,3,7,12
Change from baseline of 100mm-VAS about Motion pain in study knee at week 1,2,3,7,12
Time Frame: week 1,2,3,7,12
week 1,2,3,7,12
Change from baseline of 100mm-VAS about Night pain in study knee at week 1,2,3,7,12
Time Frame: week 1,2,3,7,12
week 1,2,3,7,12
Change from baseline of WOMAC Index total score at Week 1,2,3,7,12
Time Frame: week 1,2,3,7,12
week 1,2,3,7,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dong-A ST Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Myung chul Lee, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DA5202_KOA_II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings