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Completed

NCT Number: NCT05930080

Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial

Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult males and females aged 20 to 75 years
  • Kellgren-Lawrence (KL) grade 1 to 3
  • Individuals who voluntarily decide to participate in the study and provide written informed consent form
  • Individuals who can understand and follow instructions and can participate in the study during the entire study period

Exclusion criteria

  • Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator
  • Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint
  • Individuals who have undergone knee joint arthroplasty
  • Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit

Treatment and study plan

SKCPT

Drug

the randomly assigned subjects took the study drug for 12 weeks

Celebrex

Drug

the randomly assigned subjects took the study drug for 12 weeks

Primary outcomes

  1. K-WOMAC Pain Subscale

    Time frame: 84 days

    The average changes in the K-WOMAC(Western Ontario and McMasters Universitis) Pain Subscale (range: 0-100 mm, higher scores mean a worse outcome)

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2023
Registry last updated
Jul 6, 2023

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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