A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee

April 10, 2018 updated by: Huons Co., Ltd.
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

232

Phase

  • Phase 3

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

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain
  • Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months
  • Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm
  • Able to walk without assistive devices
  • Patients willing and able to provide signed informed consent after the nature of the study has been explained

Exclusion criteria:

  • Body Mass Index (BMI) > 32
  • History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
  • Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
  • Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test
  • Undergo Knee Replacement Surgery of the target knee

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
Intervention / Treatment
EXPERIMENTAL: Humia inj.
Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj.
Drug: Humia inj.

Single injection of 3mL Humia inj.

Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
ACTIVE_COMPARATOR: High Hyal Plus inj.
Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks
Drug: High hyal Plus inj.
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of Weight-bearing pain (100mm-VAS)
Time Frame: Week 14
Week 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of Weight-bearing pain (100mm-VAS)
Time Frame: Weeks 3, 8, 14, and 26
Weeks 3, 8, 14, and 26
Change from Visit 8 of Weight-bearing pain (100mm-VAS)
Time Frame: Week 38
Week 38
Physical Examination : Swelling
Time Frame: Weeks 0, 3, 8, 14, 26, and 38
Weeks 0, 3, 8, 14, 26, and 38
Physical Examination : Tenderness on pressure
Time Frame: Weeks 0,3,8,14,26,and 38
Weeks 0,3,8,14,26,and 38
Physical Examination : Range of motion
Time Frame: Weeks 0, 3, 8, 14, 26, and 38
Weeks 0, 3, 8, 14, 26, and 38
Consumption of rescue medication
Time Frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Proportion (%) of patients taking rescue medication
Time Frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Responder Rate
Time Frame: Week 14
Week 14

Collaborators and Investigators

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

Sponsor

Huons Co., Ltd.

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

August 1, 2016

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (ESTIMATE)

September 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-025 P3

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.

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