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OpenTrials
Completed

NCT Number: NCT02893098

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

A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial

Completed

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Key information

Conditions

Osteoarthritis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huons

Ansan-si, Gyeonggi-do, 15588, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Humia inj.

Drug

Single injection of 3mL Humia inj.

Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks

High hyal Plus inj.

Drug

Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks

Primary outcomes

  1. Change from baseline of Weight-bearing pain (100mm-VAS)

    Time frame: Week 14

Secondary outcomes

  1. Change from baseline of Weight-bearing pain (100mm-VAS)

    Time frame: Weeks 3, 8, 14, and 26

  2. Change from Visit 8 of Weight-bearing pain (100mm-VAS)

    Time frame: Week 38

  3. Physical Examination : Swelling

    Time frame: Weeks 0, 3, 8, 14, 26, and 38

  4. Physical Examination : Tenderness on pressure

    Time frame: Weeks 0,3,8,14,26,and 38

  5. Physical Examination : Range of motion

    Time frame: Weeks 0, 3, 8, 14, 26, and 38

  6. Consumption of rescue medication

    Time frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38

  7. Proportion (%) of patients taking rescue medication

    Time frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38

  8. Responder Rate

    Time frame: Week 14

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 8, 2016
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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